Republic Acts | Philippine Veterinary Medical Association

Declaring The Third Week Of February Of Each Year As Veterinary Medicine Week

An Act To Regulate The Practice Of Veterinary
Medicine In The Philippines, Repealing For The Purpose
Republic Act No. 382 And For Other Purposes

Republic of the Philippines

Congress of the Philippines

Twelve Congress

Third Regular Session

Begun and held in Metro Manila, on Monday, the twenty-eight day of July, two thousand and three.

REPUBLIC ACT NO. 9268

AN ACT TO REGULATE THE PRACTICE OF VETERINARY MEDICINE IN THE PHILIPPINES, REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 382 AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

ARTICLE I

TITLE, POLICY AND DEFINITION OF TERMS

Section 1. Title. ? This act shall be known as "The Philippine Veterinary Medicine Act of 2004."

Section 2. Declaration of Policy. ? It shall be the policy of the State to upgrade the practice of veterinary medicine for the purpose of protecting the animal population in the country through safe and proper diagnosis, treatment and surgery of these animals. The state recognizes the important role of veterinarians in nation building and promotes the sustained development of veterinarians whose competence has been validated by honest and credible licensure examination and whose standards of professionals practice and service are world-class and internationally recognized and globally competitive.

Section 3. Objectives. ? This Act provides for and shall govern:

1. The administration and conduct of licensure examination, registration and licensing of veterinarians;
2. The supervision and regulation of the practice of veterinary medicine;
3. The integration of veterinarians under an accredited veterinary professional organization; and

Section 4 Definition of Terms.

(a) "Veterinarian" - is a natural person who has been registered and issued a valid Certificate of Registration and Professional Identification Card by the Professional Regulatory Board of Veterinary Medicine in accordance with this Act.

(b) "Accredited Professional Organization" ? refers to the professional organization of veterinarians accredited by the Board and the Commission.

ARTICLE II

PROFESSIONAL REGULATORY BOARD OF VETERINARY MEDICINE

Section 5. Composition of the Board. ? There shall be created a Professional Regulatory Board of Veterinary Medicine, hereafter referred as the Board, under the administrative supervision and control of the PRC, hereinafter refer to as the commission, to be composed of the Chairman and two (2) members, who shall be appointed by the President of the Philippines from among a list of three (3) recommendees for each position submitted by the Commission from a list of five (5) nominees for each position submitted by the accredited professional organization of veterinarians.

Section 6. Qualification of Members of the Board. ? The members of the Board must at the time of nomination, recommendation, and appointments:

(a) be a Filipino citizen and resident of the Philippines for at least five (5) years immediately preceding nomination, recommendation and appointment;

(b) be a good health, sound mind, good moral character and reputation and have been convicted by final judgment of any crime involving moral turpitude;

(c) be a registered veterinarian and holder of a valid Certificate of Registration and a valid Professional Identification Card;

(d) be a member of good standing of the accredited professional organization;

(e) not be a member of the faculty whether full time, part time or as lecturer, or any school, college or university where a regular course in veterinary medicine is taught, or be a member of a staff or reviewers in a review school or center, and not have any direct or indirect pecuniary interest in any such institution;

(f) have practiced veterinary medicine for ten (10) years; and

(g) not be an officer of the accredited professional organization at eh time of nomination.

Section 7. Term of Office. ? The chairperson and the two (2) members of the Board shall hold office for a term of three (3) years from the date of appointments until their successors shall have been appointed and duly qualified and may be reappointed once. The member serving the last year of his/her term shall automatically become the chairperson of the Board. Vacancies in the Board shall be filled f or the unexpired portion of the term only. Each member shall take the proper oath prior to assumption of duty. Upon effectivity of this Act, the incumbents whose term have not yet expired or who are holdover status shall be allowed to served the unexpired portion of their terms.

Section 8. Powers, Functions, Duties and responsibilities of the Board. ? The Board shall have the following specific powers, functions, duties and responsibilities.

(a) Enforce, Administer, and implement the provisions of this Act;

(b) Determine and evaluate the qualifications of the applicants for examination, registration and for issuance of Certificate of Registration and Professional Identification Cards and/or special permits pursuant to the provision of this Act;

(c) Prepare, adopt =, issue and amend the syllabi for the subjects in the licensure examination, in consultation with the Commission on Higher Education (CHED), the academe and the accredited professional organization;

(d) Register successful examinees in the licensure examination and issue the corresponding Certificate of Registration;

(e) Enroll and registry book of veterinarian the names of successful examinees and to issue Certificate of Registration and Professional Identification Card;

(f) Prescribe guidelines providing the continuing professional education (CPE) program of registered and licensed veterinarians upon recommendation of the accredited professional organization of veterinarians;

(g) Revoke Certificate of Registration of or suspend registered and licensed veterinarians from the practice of his/her profession or to cancel special temporary permits after due notice and hearing;

(h) Adopt and administer a Code of Ethics and a Code of Technical Standards fro Doctors of Veterinary Medicines;

(i) Hear or investigate on its own or by delegation to a board member and a legal hearing officer of the Commission cases arising from violations of this Act, the Rules and Regulations, Code of Ethics and Code of Technical Standards issued thereafter and, in connection therewith, to issue subpoena ad testificandum and subpoena duces terum to alleged violators or witnesses to compel their attendance and the production of documents;

(k) Recommend to the CHED, in coordination with accredited professional organization, the prescribing, amending and/or revising of the collegiate course leading to the degree of Doctor of Veterinary Medicine;

(l) Adopt the official seal of the Board;

(m) Promulgate such as rules and regulations or administrative orders and issuances as may be necessary to properly and fully carry out the provisions of this Act; and

(n) Perform such other functions And duties as may be necessary to implement of this Act.

The policies, resolutions, rules and regulations issued or promulgated by the Board shall be subject to review and approval by the Commission. However, the Board decision?s resolution or orders which are not interlocutory, rendered in an administrative case, shall be subject to review only if an appeal with the Commission. The decision of the Board and/or the Commission may be appealed to the Court of Appeals in accordance with the Rules of Court.

Section 9. Compensation and Allowances of the Board.- The chairman and members of the Board shall receive compensation and allowances comparable to the compensation and allowances received by existing regulatory boards under the Commission as provided for the General Appropriation Act.

Section10. Removal of the Board Members. ? The chairman and members of the Board may be removed from the office of the President of the Philippines, upon recommendation of the Commission on the following grounds:

(a) Neglect of duty;

(b) Incompetence;

(c) Violation of Republic Act No. 6713, otherwise known as "The Code of Conduct and Ethical Standards for Public Officials and Employees," and " The Code of Ethics of the Veterinary Medicine Profession;"

1. Manipulation or rigging of the veterinary licensure examination results;
2. Disclosure of the examination questions or similar secret information;
3. Tampering of the grades therein; and
4. Final conviction by the court of criminal offense involving moral turpitude.

Section 11. Administrative Supervision of the Board, Custodian of its Records, Secretariat and its Support Services.- The Board shall be under the administrative and executive management of the Commission. All records of the Board, including the applications for examination, minutes of deliberations, and administrative and other investigative cases shall be under the custody of the Commission. The Commission shall designate the Secretary of the Board and shall provide the secretariat and support services to implement the provision of this Act.

Section 12. Annual Report.- The Board shall, after the close of the fiscal year, submit an annual report to the Commission giving a detailed report of the activities and proceedings of the Board during the year and embodying such recommendations as the Board may be desire to make.

ARTICLE III

EXAMINATION AND REGISTRATION OF VETERINARIANS

Section 13. Examination Required.- Except as otherwise specially allowed under this Act, all applicant for registration for the practice of veterinary medicine shall be required to pass the licensure examination to be given by the Board and the Commission in such places and dates as the Commission may designate in accordance with Republic Act No. 8981, subject to compliance with the requirements prescribed by the Commission.

Section 14. Subjects Covered by the Examination.- The subjects for the licensure examination, shall cover the following:

1. Veterinary Parasitology;
2. Veterinary Pharmacology
3. Veterinary Medicine (including Ethics, Surgery, Animal Welfare and Jurisprudence);
4. Zootechnics (including Animal Behavior and Environmental Health);
5. Veterinary Microbiology and Veterinary Public Health;
6. Veterinary Physiology
7. Veterinary Anatomy; and
8. Veterinary Pathology.

The Board may be amend, modify or exclude any of the subjects in any syllabi and new ones as technological need arises subject to the approval of the Commission.

Section 15. Qualifications of Applicant for Examination. ? In order to qualify for examination, an applicant shall establish to the satisfaction of the Board that:

(a) he/she is a citizen of the Philippines or a foreigner whose country has reciprocity with the Philippines in the practice of veterinary medicine;

(b) he/she is in good health and moral character, and sound mind;

(c) he/she has not been convicted by the final judgment of an offense involving moral turpitude by a competent court; and

(d) he/she is a holder of a Degree in Veterinary Medicine from a recognized accredited College of Veterinary Medicine by the Commission on Higher Education (CHED).

Section 16. Report of Ratings. ? The Board shall, with ten (10) days or earlier after the date of examination, report the rating obtained by each candidate to the Commission for official release and publication.

Section 17. Ratings in Examination. ? In order to pass the examination, a candidate must obtain a weighted average of at least seventy-five percent (75%) with no rating below sixty percent (60%)in any subject. A candidate who obtains an average rating of seventy-five percent (75%) or higher but gets a rating below sixty percent (60%) in any subject shall be allowed to take a re-examination in only those subjects in which he/she obtained a rating below sixty percent (60%). Should he/she fails to obtain seventy-five percent (75%) in reported subject or subjects, his/her examination shall be considered as failed, and he/she shall be required to take all the subjects in the next examination.

Section 18. Issuances of Certificate of Registration and Professional Identification Card.- A certificate of Registration as a veterinarian shall be issued to an applicant who passes the examination or who is registered without examination and shall indicate the full name of the registrant, serial number, date of issuance bearing the signature of the Commission of Chairperson and the chairman and members of the Board, with the official seal of the Board and the Commission.

A Professional Identification Card bearing the registration number, date of issuance, expiry date, duly signed by the Commission Chairperson, shall likewise be issued to every registrant who has paid the prescribed fee.

Section 19. Fees for Examination, Registration of License. ? Applicants for examination and registration and for the issuance of a Professional Identification Card shall pay the fees prescribed by the Commission.

Section 20. Oath.- All successful examinees and registrants without examination shall required to take a oath before any member of the Board or any official authorized by the Commission or any government official authorized by law before they start their practice.

Section 21. Refusal to Register. ? The Board shall refuse to register an applicant as a veterinarian and to issue his/her Certificate of Registration and Professional Identification Card if he/she is convicted of any criminal offense involving moral turpitude, or found guilty of immoral or dishonorable conduct, or he/she is declared by the court to be of unsound mind or have violated the Animal Welfare Act. The Board shall furnish the applicant a written statement settings forth the reasons for its action which shall be incorporated in the records of the Board.

Section 22. Revocation of Certificate of Registration and Suspension from the Practice of Veterinary Medicine and Cancellation of Special Permit.- The Board shall have the power to reprimand or suspend any person from the practice of the veterinary medicine, revoke the Certification of Registration of any registered veterinarian, or cancel special permit issued upon any of the following ground:

1. any of the cause mentioned in this Section 21;
2. unprofessional and unethical conduct;
3. gross incompetence, gross negligence, gross ignorance or any other acts of malpractice resulting in the disability, disfigurement or death of an animal;
4. use of fraud, deceit, or false statements in obtaining registration, Certificate of Registration, Professional Identification Card, or special permit;
5. for chronic inebriety or habitual substance abuse;
6. having professional connection with or lending one?s name to an illegal practitioner of veterinary medicine;
7. fraud or dishonesty in applying, teaching or report on any laboratory test and research findings.
8. False misleading advertising, having for its purpose or intent deception or fraud;
9. Knowingly and deliberately concealing or failing of report as required by law, or making false reports regarding the spread of contagious or infectious diseases;
10. Violation of rules and regulations, Code of Ethics, Code Technical Standards and other policies of the Board and the Commission issued pursuant to this Act; or
11. Practicing his/her profession during the period of his/her suspension from the practice of his profession.

Section 23. Rights of Respondent. ? The respondent registered veterinarian shall entitled to counsel, a speedy public hearing, and to confront and cross-examine witnesses against him.

Section 24. Administrative Investigation. ? Within five (5) day after filing written charges under oath, respondent registered veterinarian shall be furnished a copy thereof requiring him to answer the same. The administrative investigation shall be conduced by the Board, or any of its members as may be designated by the Commission, on cases involving the practice of the profession: Provided, however, That the decision shall be promulgated by the Board.

Section 25. Appeal.- The decision of the denial or refusal to issue Certificate of Registration, the revocation or suspension of Certificate of Registration, and the cancellation of special permit by the Board shall be final unless appealed to the Commission within fifteen (15) day from receipt of the decision. The decision of the Board and/or Commission may be appealed to the Court of Appeals.

Section 26. Reinstatement.- Subject to the approval of the Commission, a person may apply to the Board for reinstatement of his/her Certificate of Registration/professional license any time after the expiration of one (1) year from the date of revocation of said certificate. The application shall be writing and shall conform the requirements provided by the Board. No certificate shall be reinstated unless the Board is satisfied that a good cause exists to warrant such reinstatement.

Section 27. Indication of the Certificate of Registration and Professional Identification Card and Professional Tax Receipt. ? A registered and licensed veterinarian shall indicate his/her Certificate of Registration/Professional Identification Card with date of issue and expiry, and the Professional Tax Receipt number, on the prescription and other documents he/she signs, uses, or issues in connection with the practice of his/her profession.

Section 28. Automatic Registration.- All veterinarians whose names appears in the roster of veterinarians shall be automatically or ipso facto registered as veterinarians under this Act.

ARTICLE IV

PRACTICE OF VETERINARY MEDICINE

Section 29. Acts of Constituting Practice of Veterinary Medicine. ? A person who is authorized to practice veterinary medicine under this Act shall append or cause to be appended to his name the letters D.V.M. (Doctor of Veterinary Medicine), V.M. D. (Veterinary Medical Doctor), D.V.S.(Doctor of Veterinary of Science), the words "Veterinarian, " Veterinary Surgeon, " Veterinary Dentist," or "Veterinary" any other initial or title implying qualification to practice, offer or render, for a fee or otherwise, services such as:

(a) the examination and/or diagnosis, treatment, operation of, or the prescribing and dispensing of any remedy for, any injury to or diseases, ailment or deformity of animals;

(b) attesting for official or commercial purpose to the health of any terrestrial, aquatic, domestic or non-domestic animals;

(d) attesting to the fitness for human consumption of animal products and by-products;

(e) holding of any job or position in a public or private entity which requires knowledge of or skill in veterinary medicine; or

(f) teaching or lecturing of veterinary clinical subjects in the curriculum of the degree in veterinary medicine.

Provided, That the enumeration of the above practices or services in this Section shall not be construed as excluding any other work requiring knowledge and application of professional veterinary medicine which the Board may specify, upon the recommendation of accredited professional organization in Veterinary Medicine.

Section 30. Unlawful Practice of Veterinary Medicine. ? It shall be unlawful for any person to practice veterinary medicine and any of its allied branches, including veterinary dentistry, without a valid and existing Certificate of Registration and Professional Identification Card issued by the Board of Veterinary Medicine and the Commission.

Section 31. Foreign Reciprocity. ? No foreigner shall be admitted to the examination or be registered as veterinarian under this Act unless he/she proves that the country of which he/she is a citizen of, either permits Filipino citizens to practice veterinary medicine without need for registration, without restriction, or allows them to practice after an examination on term of strict and absolute quality with nationals of said country.

Section 32. Roster of Veterinarian. ? The Board shall keep a roster of the names, residence and office address of all registered and licensed veterinarians. The said roster shall be made available to the public upon request and payment of prescribed fees thereof.

Section 33. Penal Provision. ? The following persons shall be punished:

(a) Any person who shall practice veterinary medicine within the meaning of this Act without a valid Certificate of Registration and a Professional Identification Card or a valid special permit issued in accordance herewith;

(b) Any person presenting or using as his or her own Certificate of Registration or Professional Identification Card of another

(c) Any person who shall give any false or forged evidence of any kind to the Board or the Commission in obtaining any of the foregoing documents;

(d) Any person who shall falsely impersonate any registrant with like or different name;

(e) Any registered and licensed veterinarian who shall abet or assist illegal practice of a person who is not lawfully qualified to practice veterinary medicine;

(f) Any person who shall attempt to use a revoked or suspended Certificate of Registration or any invalid or expired Professional Identification Card or a cancelled special permit;

(g) Any person assuming, using or advertising any title, description tending to convey the impression that he or she is a registered and licensed veterinarian; or

(h) Any person who violates any provision of this Act and its rules and regulations shall, upon conviction be punished by a fine of not less than Fifty Thousand Pesos (50,000.00) nor more than One Hundred Thousand Pesos (100,000.00) or by imprisonment of not less than one (1) year nor more than five (5) years or both fine and imprisonment for each and every offense at the discretion of the court.

Section 34. Enforcement. ? The Commission shall implement the provision of this Act, enforce its implementing rules and regulations as adopted by the Board and assist the Board in the investigation of complaint against violators of this Act, its rules and regulations and other policies of the Board.

The Commission shall call upon or request any department, instrumentality, office, bureau, or agency of the government including local government units to render such assistance as it may require to coordinate or cooperate in order to carry out, enforce or implement the provision of this Act.

Section 35. Funding Provision. ? The Chairperson of the PRC shall immediate include in the Commission?s programs the implementation of this Act, the funding of which shall be included in the annual General Appropriate Act.

Section 36. Implementing Rules and Regulations. ? Within sixty (60) days after the effectivity of this Act, subject to the approval of the Commission, the Board in coordination with the accredited professional organization, shall promulgate the necessary rules and regulations to implement the provisions of this Act, which shall be effective after fifteen (15) days following its publication in the Official Gazette or newspaper of general circulation.

Section 37. Separability Clause. ? If any part of this Act is declared unconstitutional, the remaining parts not affected thereby shall continue to be valid and operational.

Section 38. Repealing Clause. ? Republic Act No. 382 and all other laws, decrees, orders, circulars, rules and regulations, and other issuances, and part thereof which are inconsistent with this Act are hereby superseded, repealed, amended, or modified accordingly.

Section 39. Effectivity. ? This Act shall take effect thirty (30) days after its publication in the Official Gazette or in any newspaper of general circulation.

Approved,

(Sgd.) FRANKLIN M. DRILON	(Sgd.) JOSE DE VENECIA JR.
President of the Senate	Speaker of the House of Representative

This Act which is a consolation of House Bill No. 6002 and Senate Bill No. 2578 was finally passed by the House of Representatives and the Senate on January 20, 2004 and January 19, 2004, respectively.

(Sgd.) OSCAR G. YABES	(Sgd.) ROBERTO P. NAZARENO
Secretary of the Senate	Secretary General House of Representatives

Approved: MAR 19, 2004

(Sgd) GLORIA MACAPAGAL-ARROYO

President of the Philippines

An Act To Promote Animal Welfare In The Philippines,
Otherwise Known As "The Animal Welfare Act Of 1998"

Republic of the Philippines

Congress of the Philippines

Metro Manila

Tenth Congress

Third Regular Session

Begun and held in Metro Manila on Monday the twenty-eight day of July, nineteen hundred and ninety-seven.

REPUBLIC ACT 8485

AN ACT TO PROMOTE ANIMAL WELFARE IN THE PHILIPPINES, OTHERWISE KNOWN AS ?THE ANIMAL WELFARE ACT OF 1998?

Be it enacted by the Senate and House of Representative of the Philippines in Congress Assembled:

Section 1. It is the purpose of this Act to protect and promote the welfare of all animals in the Philippines by supervising and regulating the establishment and operations of all facilities utilized for breeding, maintaining, keeping, treating or training of all animals either as objects of trade or as household pets. For purposes of this Act, pet animal shall include birds.

Section 2. No person, association, partnership, corporation, cooperative or any government agency or instrumentality including slaughterhouses shall establish, maintain and operate any pet shop, kennel, veterinary clinic, veterinary hospital, stockyard, corral, stud farm or stock farm or zoo for the breeding, treatment, sale or trading, or training of animals without first securing from the Bureau of Animal Industry a certificate of registration therefor.

The certificate shall be issued upon proof that the facilities of such establishment for animals are adequate, clean and sanitary and will not be used for nor cause pain and/or suffering to the animals. The certificate shall be valid for a period of one (1) year unless earlier cancelled for just cause before the expiration of its term by the Director of the Bureau of Animal Industry and may be renewed from year to year upon compliance with the conditions imposed hereunder. The Bureau shall charge reasonable fees for the issuance or renewal of such certificate.

The condition that such facilities be adequate, clean and sanitary and that they will not be used for nor cause pain and/or suffering to the animals is a continuing requirement for the operation of these establishments. The Bureau may revoke or cancel such certificate of registration for failure to observe these conditions and other just causes.

Section 3. The Director of the Bureau of Animal Industry shall supervise and regulate the establishment, operation and maintenance of pet shop, kennels, veterinary clinics, veterinary hospitals, stockyards, corrals, stud farms and zoos and any other form or structure for the confinement of animals where they are bred, treated, maintained, or kept either for sale or trade or for training purposes as well as the transport of such animals in any form of public or private transportation facility in order to provide maximum comfort while in transit and minimize, if not totally eradicate, incidence of sickness and death and prevent any cruelty from being inflicted upon the animals.

The Director may call upon any government agency for assistance consistent with its powers, duties and responsibilities for the purpose of ensuring the effective and efficient implementation of this Act and the rules and regulations promulgated thereunder.

It shall be the duty of such government agency to assist said Director when called upon for assistance using any available fund in its budget for the purpose.

Section 4. It shall be the duty of any owner or operator of any land, air or water public utility transporting pet, wildlife and all other animals to provide in all cases adequate, clean and sanitary facilities for the safe conveyance and delivery thereof to their consignee at the place of consignment. They shall provide sufficient food and water for such animals while in transit for more than twelve (12) hours or whenever necessary.

No public utility shall transport any such animal without a written permit from the Director of the Bureau of Animal Industry or his/her authorized representative. No cruel confinement or restrain shall be made on such animals while being transported.

Any form of cruelty shall be penalized even if the transporter has obtained a permit from the Bureau of Animal Industry. Cruelty in transporting includes overcrowding, placing of animals in the trunks or under the hood trunks of the vehicles.

Section 5. There is hereby created a Committee on Animal Welfare attached to the Department of Agriculture which shall, subject to the approval of the Secretary of the Department of Agriculture, issue the necessary rules and regulations for the strict implementation of the provisions of this Act, including the setting of safety and sanitary standards within thirty (30) calendar days following its approval. Such guidelines shall be reviewed y the Committee every three (3) years from its implementation or whenever necessary.

The Committee shall be composed of the official representatives of the following:

The Department of Interior and Local Government (DILG);

Department of Education, Culture and Sports (DECS);

Bureau of Animal Industry (BAI) of the Department of Agriculture (DA);

Protected Areas and Wildlife Bureau (PAWB) of the Department of Environment and Natural

Resources (DENR);

National Meat Inspection Commission (NMIC) of the DA;

Agriculture Training Institute (ATI) of the DA;

Philippine Veterinary Medical Association (PVMA);

Veterinary Practitioners Association of the Philippines (VPAP);

Philippine Animal Hospital Association of the Philippines (PAHA);

Philippine Animal Welfare Society (PAWS);

Philippine Society for the Prevention of Cruelty to Animals (PSPCA);

Philippine Society of Swine Practitioners (PSSP);

Philippine College of Canine Practitioners (PCCP); and

Philippine Society of Animal Science (PSAS).

The Committee shall be chaired by a representative coming from the private sector and shall have two (2) vice-chairpersons composed of the representative of the BAI and another from the private sector.

The Committee shall meet quarterly or as often as the need arises. The Committee members shall not receive any compensation but may receive reasonable honoraria from time to time.

Section 6. It shall be unlawful for any person to torture any animal or to neglect to provide adequate care, sustenance or shelter, or maltreat any animal or to subject any dog or horse to dogfights or horse fights, kill or cause or procure to be tortured or deprive of adequate care sustenance or shelter, or maltreat or use the same in research or experiments not expressly authorized by the Committee on Animal Welfare.

The killing of any animal other than cattle, pigs, goats, sheep, poultry, rabbits, carabaos, horses, deer and crocodiles is likewise hereby declared unlawful except in the following instances:

(1) When it is done a part of the religious rituals of an established religion or sect or ritual required by tribal or

ethnic custom of indigenous cultural communities; however, leaders shall keep records in the cooperation

with the Committee on Animal Welfare;

(2) When the pet animal is afflicted with an incurable communicable disease as determined by a duly licensed

veterinarian;

(3) When the killing is deemed necessary to put an end to the misery suffered by the animal as determined

and certified by a duly licensed veterinarians;

(4) When it is done to prevent an imminent danger to the life or limb of a human being;

(5) When done for the purpose of animal population control;

(6) When the animal is killed after it has been used in authorized research or experiments; and

(7) Any other ground analogous to the foregoing as determined and certified by a licensed veterinarian.

In all the above mentioned cases, including those of cattle, pigs, goats, sheep, poultry, rabbits, carabaos, horses, deer and crocodiles the killing of the animals shall be done through humane procedures at all times.

For this purpose, humane procedure shall mean the use of the most scientific methods available as may be determined and approved by the committee.

Only those procedures approved by the Committee shall be used in killing of animals.

Section 7. It shall be the duty of every person to protect the natural habitat of the wildlife. The destruction of said habitat shall be considered as a form of cruelty to animals and its preservation is a way of protecting the animals.

Section 8. Any person who violates any of the provisions of this Act shall, upon conviction by final judgment, be punished by imprisonment of not less than six (6) months nor more than two (2) years or a fine not less than One thousand pesos (P1,000.00) nor more than Five thousand pesos (P5,000.00) or both at the discretion of the Court. If the violation is committed by a juridical person, the officer responsible therefore shall serve the imprisonment when imposed. If the violation is committed by an alien, he or she shall be immediately deported after services of sentence without any further proceedings.

Section 9. All laws, acts, decrees, executive orders, rules and regulations inconsistent with the provisions of this Act are hereby repealed or modified accordingly.

Section 10. This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.

Approved.

(Sgd.) JOSE DE VENECIA, JR. (Sgd.) NEPTALI A. GONZALES

Speaker of the House of Representatives President of the Senate

This Act, which is a consolidation of Senate Bill No. 2120 and House Bill No. 9274 was finally passed by the Senate and the House of Representatives on February 3, 1998 and February 2, 1998 respectively.

(Sgd.) ROBERTO P. NAZARENO (Sgd.) HEZEL P. GACUTAN

Secretary General Secretary of the Senate

House of Representatives

Approved:

February 11, 1998

(Sgd.) FIDEL V. RAMOS

President of the Philippines

An Act To Regulate The Sale Of Veterinary
Biologics And Medicinal Preparations.

REPUBLIC ACT NO. 1071

AN ACT TO REGULATE THE SALE OF VETERINARY BIOLOGICS AND MEDICINAL PREPARATIONS.

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1. For purposes of this Act, the terms ?veterinary biologics?, ?veterinary medicinal preparations?, ?livestock?, ?poultry?, and ?house pets? are to be construed to mean:

(a) Veterinary biologics are preparations which include serum and bacterial and viral products from biological laboratories.

(b) Serum for veterinary use, be it normal or immune, are those for the diagnosis, treatment and prevention of diseases of different species of livestock poultry and house pets.

(c) Bacterial and viral products for veterinary use, including vaccines and antigens, are those for the diagnosis of, and immunization against diseases of livestock, poultry and house pets.

(d) Medicinal preparations for veterinary use, are, those pharmaceutical products for the treatment and prevention of diseases as well as for other purposes in the protection and improvement of livestock, poultry and house pets.

(e) Livestock comprises the mammalian animals, and poultry, the avian animals which are domesticated and kept or raised in backyards or on farms.

(f) House pets are those animals which are kept in homes like dogs, cats, rabbits, birds, etc.

Section 2. It shall be unlawful for any agency or store or sell to the public veterinary biologics and medicinal preparations other than registered pharmacies or drugstores (boticas), biological laboratories, veterinary clinics and government veterinary agencies.

Section 3. The manager or proprietor of any agency, store, or entity which fails to comply with the provisions of this Act shall be guilty of misdemeanor, and upon conviction shall be punished by a fine of not less than one hundred pesos nor more than two hundred pesos or by imprisonment for not less than thirty days nor more than six months, or by both fine and imprisonment for each offense, and shall be the duty of the Provincial or City Fiscal where such offense is committed to prosecute all persons violating the provisions of this Act, upon proper complaint being made. All fines collected under this Act shall be paid into the treasury of the province or city where the prosecution is held.

Section 4. This Act shall take precedence above all existing rules and regulations regarding the sale of veterinary biologics and medicinal preparations in the Philippines.

Section 5. This Act shall take effect upon its approval.

Approved, June 15, 1954.

An Act To Regulate And Control The Manufacture, Importation,
Labeling, Advertising, And Sale Of Livestock And Poultry Feeds
And Providing Funds Therefore.

THIRD CONGRESS

of the

Republic of the Philippines

Third Session

Begun and held in the City of Manila on Monday, the twenty-third day of January, nineteen hundred fifty six.

REPUBLIC ACT. NO. 1556 (As Amended by S.B. No. 627)

AN ACT TO REGULATE AND CONTROL THE MANUFACTURE, IMPORTATION, LABELING, ADVERTISING, AND SALE OF LIVESTOCK AND POULTRY FEEDS AND PROVIDING FUNDS THEREFORE.

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1. This Act shall be known as the Livestock and Poultry Feeds Act.

Section 2. Enforcing Official. ? This act shall be administered by the Secretary of Agriculture and Natural Resources thru the director, Bureau of Animal Industry.

Section 3. Definitions. ? For the purpose of this Act, the following terms shall mean:

(a) ?Secretary? means the Secretary of Agriculture and Natural Resources.

(b) ?Director? means the Director, Bureau of Animal Industry.

(c) ?Livestock? means and include horses, cattle, carabaos, sheep, swine, rabbits, poultry and such other animals or birds as the Secretary may, from time to time by regulation, prescribe.

(d) ?Feeds? or Feeding Stuff? shall embrace all such articles to be used as feeds purporting to supply proteins, carbohydrates, fats, mineral, vitamins, antibiotics, growth promoting factors whether identified or unidentified, and/or correcting nutritional disorders. Such articles may be locally produced or imported, mixed or in the form of simple ingredients; Provided, however, that the following excluded:

(1) Whole seeds or grains, unmixed.

(2) Fresh green roughage and unprocessed liquid milk in all its forms.

(3) Dried and ground hays and straws, dried and ground corn stalks or other parts of the corn plant not included in the grain, rice hulls, cane sugar bagasse, dried beet pulp, oat hulls, barley hulls, clipped oat by-products, sorghum plant by-products and flax plant by-products, cotton seed hulls, mongo bean hulls, buckwheat hulls, cocoa shells, or other materials of a similar character.

(e) ?Owner? is the person, firm, partnership, cooperative, association or corporation applying for the required registration under this Act or any person or establishment actually engaged in the manufacture, importation, distribution, and sale of livestock and poultry feed.

(f) ?Brand? means any distinctive mark or name applied to a feed or feeding stuff.

(g) ?Inspector? is any person authorized to enforce the provisions of the Act.

(h) ?Package? means sack, bag, barrel, bin or any other container for feeds.

(i) ?Label? means and includes any written, printed or graphic matter attached or affixed to any package, bale or bundle of feeds.

(j) ?Regulations? means rules prescribed under the authority of this Act.

(k) ?Analyst? means any official analyst appointed or designated as such by the director of Animal Industry for the purpose of implementation of this Act.

(l) ?Ingredients? means any single articles of feed or feeding stuff which enters into the composition of a ration, concentrate, or supplement.

(m) ?Mixture? means any combination of two or more feed ingredients used in the manufacture of feeding stuff.

(n) ?Concentrate? shall apply to feedstuffs low in fiber and high in total digestible nutrients.

(o) ?Roughages? shall include dried and ground hays and straws, dried and ground corn stalks or other parts of the corn plant not included in the grain, dried beet pulp, oat hulls, barley hulls, clipped oat by-products, sorghum plant by-products and flax plant by-products, cotton seed hulls, buckwheat hulls, cocoa shells, grain screening or other materials of a similar character. This shall not include ?Adulterated Feed? or mixed material that is proven injurious, damaged or of no food value or if any substance has been added thereto thus increasing its bulk or weight or reducing its quality and strength. For purposes of this Act a mixture of two or more mixed feeds of different formulas or brand with intent to sell is also considered adulterated feed.

Section 4. Registration ? (a) any person, partnership, firm, corporation or association desiring to engage in the manufacture, importation, sale or distribution of feeds or feeding stuffs shall first be registered in the office of the director, Bureau of Animal Industry.

(b) Application for registration or annual renewal thereof, shall be made by the person, partnership, cooperative, firm corporation, or association, marketing, manufacturing, importing, indenting, or distributing such feeds or feeding stuffs, or by his accredited agent in such form and manner as may be prescribed form time to time by regulations. Each type or kind of feed or feedstuffs manufactured or imported shall be registered separately.

(c) An application for registration shall be accompanied by a registration fee of five pesos for each store registered by a person, firm, cooperative, partnership, corporation, or association engaged in retailing commercial feeds or feeding stuffs, fifty pesos for distributors, one hundred pesos for local feedstuffs suppliers with gross sales of one hundred pesos or more, two hundred pesos for importers and/or indentors and three hundred pesos for manufacturers of commercial feeds or feeding stuffs. The registration fee shall be payable at the option of the person, partnership, firm cooperative, corporation or association engaged in the manufacture, importation, sale or distribution of feeds or feeding stuffs, annually, on or before the twenty first of January, or semi-annually, on or before the thirty-first of January and July. When a business is newly opened during any year the registration fee shall be reckoned from the commencement of the current semester; and when either at any time abandoned the registration fee shall not be exacted for a longer period than to the end of the semester: Provided, that, those who elected to pay the registration fee in full shall not be entitled to a refund of the fee corresponding to the unused period for which the fee had been paid.

(d) No feeds or feeding stuffs in the form of complete mixture, concentrate, supplement, or ingredient which have not been registered with Director, shall be manufactured, imported, advertised, sold or offered for sale or held in possession for sale in the Philippines.

(e) No commercial feeds or feeding stuffs shall be registered:

If the brand thereof is identical or will likely be confused, with another brand already applied to a registered feeding stuffs;

If the specific name of each and every ingredient of mixture, base or concentrates, and supplement if not clearly stated; or

If the feeds or feeding stuffs do not conform to the provisions of this Act.

(f) No change in the brand of a registered feed of feeding stuff shall be made without a written notification to the Director.

(g) The Director may suspend, subject to the rules and regulations promulgated for the implementation of this Act, the registration of any feed and feeding stuff which is found after proper investigation to be not in conformity with the provisions of this Act, in registration, importation, manufacture, distribution, labelling, advertising for sale, unless subsequent production is proven to be innocuous, harmless and in accordance with the quality standard for the particular product set forth in the registration under this Act. Once suspended a formal investigation should be conducted thereon by the Committee created for this purpose pursuant to Section 5 of this Act. But the action of the Director of Animal Industry may be appealed to the Secretary of Agriculture and Natural Resources. Adulterated, damaged or injurious feed shall be impounded and the subsequent manufacture thereof prohibited by the Director of Animal Industry: Provided, further, that when there is a reasonable cause to believe that certain feed or feedstuffs are damaged, adulterated or injurious such feed or feedstuffs shall be immediately impounded and portion thereof sold to the public be retrieved by and at the expense of the manufacturer, importer or retailer upon notice of the Director of Animal Industry.

(h) That the Director of Animal Industry or his duly authorized representative shall have the power to investigate the sources and/or distribution or retailers of feed ingredients such as rice mills, corn mills, flour mills, cassava mills, fish mills, meat mill, ipil-ipil leaf mills and such other mills that manufacture ingredients used in the compounding of feed or feeding stuff and to require them to register under this Act.

Section 5. Labeling ? Every package containing feed or feeding stuff shall be labeled as follows:

The original label or tag of imported feeds or feeding stuffs shall remain attached to each package. In the event that the original label or tag has been lost or otherwise removed during the transit, a new label or tag shall be attached with the approval of the Director to all bags intended for sale.
Every container of feed or feeding stuff manufactured and/or distributed shall have affixed thereto a tag or label, on a conspicuous place on the outside thereof, containing a legible and plainly printed statement certifying:

(a) The net weight in metric equivalent of the contents.

(b) The name, brand or trademark and nutritive purpose.

(d) The minimum percent of crude protein.

(e) The minimum percent of crude fat.

(f) The maximum percent of crude fiber.

(g) The maximum percent of ash.

(h) The maximum percent of moisture.

(i) The maximum percent of mineral it contains.

(j) In the case of mixed feeds containing more than five (5) percent of mineral ingredients, the maximum percentage of calcium (Ca) or phosphorus (P).

(k) In the case of feeds or feeding stuffs intended to be used as feed supplements or premixes for which special qualities are claimed, such as vitamin, mineral, arsenical, surfactant, unidentified growth factor, hormone, antibiotics, and amino acid contents, a definite guarantee relative to its quality.

(l) The registration number of the particular kind of feeds or feeding stuff.

(m) The accepted or official name of each ingredient used in the manufacture.

(n) The percent of such ingredients as corn cobs, oat hulls, rice hulls, barley hulls, mongo bean hulls, cocoa shells, or similar materials when such constitute a portion of the feed or feedstuffs in quantities in excess of what is normally found in such feed stuffs.

(o) Any feeds or feed stuffs containing a substance which is toxic or poisonous if consumed in quantities greater than recommended by the manufacturer shall be so labeled that the user will be warned of the toxic or poisonous effects resulting from feeding such excess quality.

(p) Any feeds or feeding stuffs containing a non-nutritive substance which is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or any function of the animal body, shall be labeled to show the amount of such substance present directions for use, and any necessary warning against misuse.

(q) Control number, code number, or batch number and date of manufacture.font>

Labels of local grains and/or their by-products, minerals and other ingredients sold or to be sold for feed shall show conspicuously and clearly:

(a) Net weight

(b) Name of feed (e.g., rice bran, yellow corn, white corn, ipil-ipil, copra, shell powder, rice hay, etc.)

(d) Class: i.e., second or third (as prescribed by standard set by the Director)

(e) Name and address of store

(f) Registration number of store owner.

Labels of any other feed not covered in the preceding paragraphs shall be made according to regulations, which from time to tome may be prescribed by the Director with the approval of the Secretary.

Section 6. There should be created in the manner authorized by law a separate division, known as the Animal Feed Control Division, in the Bureau of Animal Industry, and providing positions thereof, for the purpose of implementing this act in so far as registration, inspection, sample collection and field investigation are concerned.

The sum of five Hundred Thousand Pesos is hereby authorized to the appropriated, out of any funds in the National Treasury not otherwise appropriated for the organization and operation of the said division during its first fiscal year. Such sums as may be necessary for its operation and maintenance in subsequent years shall be included in the annual ?General Appropriations Act?.

Section 7. The Director and/or his inspectors shall be permitted at all reasonable times to enter and inspect any premises and/or conveyances in which feeds or feed ingredients are sold, produced, processed, transported, or held in possession for sale or distribution, when he has reasonable cause to believe any feed or feeding stuff is being prepared or has been prepared for sale and may open any package containing or supposed to contain any feed or feeding stuff, and take therefrom samples for analysis without cost, and shall likewise be permitted to inspect only records or documents which are necessary in verifying the volume of production and/or importation for proper assessment of the inspection fee as provided for in this Act.

Section 8. Regulations ? The Director, upon recommendation of the Advisory Committee created under Section 5 hereof and subject to the approval of the Secretary, shall promulgate rules and regulations:

(a) Prescribing the basis under which grains and their by-products may be classified;

(b) Providing for the prevention of false and/or misleading claims that may be made for any feeding stuff;

(c) Prescribing the definition and uses of such terms as complete ration, concentrate, supplement, and/or base as used in livestock nutrition, deficient, damaged, adulterated, and injurious feeds to livestock and poultry and such other terms as may be necessary in clarifying the intention of this Act;

(d) Prescribing procedures for impounding, condemnation and/or disposition of deficient, damaged, adulterated and or injurious feed or feeding stuff: Provided, that the disposal shall be at the expense of the manufacturer, importer, distributor or retailer concerned;

(e) Prescribing methods for collection and analysis of samples;

(f) Requiring the services of licensed chemist and veterinarian or animal nutritionist by manufacturers of mixed feeds in connection with the analysis, test, formulation compounding, and mixing of feed and feeding stuff and to prescribed such other rules and regulations as may be necessary to carry out the purposes of this Act;

(g) Prescribing methods of chemical and biological tests for determining the purity and safety of feeds and feeding stuffs, and prescribing rules and regulations for the supervision and control of said testings; and

(h) Requiring the publication of the results of analysis and test of samples of feeds and feedstuffs collected from feed ingredients suppliers and feed manufacturers; said publication, at least three times in a calendar year preferably in January, May and September, should specify both which are in compliance and not in compliance with the guaranteed analysis or quality standard set forth under this Act or under the rules and regulations promulgated thereunder.

Section 9. Fees and Expenditures ? (a) Aside from the registration fees as provided in Section Four, Sub-section (c) of this Act, there shall be collected an inspection fee at the rate of twenty centavos per metric ton of all complete mixed feeds, supplement, and/or concentrates.

(b) All fees, charges and other income derived from the operation of this Act, shall accrue to the Philippine Livestock Promotion Fund as provided in Commonwealth Act Numbered One Hundred and Eighteen, as amended, and shall be deposited with the National Treasury to the credit of the said fund: Provided, however, that eighty percent of said income shall be set aside and spent only for the maintenance and improvement of services and laboratory facilities in the Bureau of Animal Industry needed in the implementation of this Act, and for training and research directly relevant to the implementation of this Act.

(c) All other expenditures necessary to carry out the purposes of this Act, including all expenditures for the Advisory Committee created under Section 5 hereof, shall be paid from the unalloted balance of the Philippines Livestock Promotion Fund created under Commonwealth Act Numbered One Hundred and Eighteen, as amended.

Section 10. Offenses and Penalties ? (a) it shall be unlawful for any person, partnership, firm, cooperative, corporation or association to engage in the manufacture, importation, sale or distribution of feeds or feeding stuff, without having first registered in accordance with this Act in the office of the Director of the Animal Industry:

(b) Any firm, partnership, cooperative, corporation or association or its President / General Manager or any person which will unlawfully use a registration number, fraudulently lessen or adulterate the feeding value of any feed or feeding stuff, or tamper with packaged feeds for fraudulent purposes, willfully removed, alter or effaced the prescribed tags, labels, markings, or other information placed on package of feeds or feeding stuffs, fraudulently alter or use certificates of analysis of any official analyst; willfully obstruct, hinder, resist, or in any other way oppose disposition of feeds placed under detention; imports, manufacture, distribute, advertise, sell or offer for sale or possess for sale any feed which does not conform with or contravenes the provisions of this Act; or otherwise violate any provision of this Act, and the rules and regulations issued thereunder, shall be punished by a fine of not less than One Thousand Pesos or by imprisonment of not more than one year and one day, or by both, in the discretion of the court aside from the fine imposed in the court.

Section 11. All acts or parts thereof inconsistent with the provisions of this Act are hereby repealed.

Section 12. This Act shall take effect thirty days from the date of its approval.

APPROVED: June 16, 1956

An Act Creating The Bureau Of Animal Industry,
Defining Its Powers And Functions, Providing For Its Personnel;
Making Appropriation For Its Organization And Operation;
Changing The Name Of The Bureau Of Agriculture
To Bureau Of Plant Industry, And Other Purposes.

REPUBLIC ACT NO. 3639

AN ACT CREATING THE BUREAU OF ANIMAL INDUSTRY, DEFINING ITS POWERS AND FUNCTIONS, PROVIDING FOR ITS PERSONNEL; MAKING APPROPRIATION FOR ITS ORGANIZATION AND OPERATION; CHANGING THE NAME OF THE BUREAU OF AGRICULTURE TO BUREAU OF PLANT INDUSTRY, AND OTHER PURPOSES.

Be it enacted by the Senate and House of Representatives of the Philippines in Legislature assembled and by authority of the same:

Section 1. Creation of the Bureau of Animal Industry- There is hereby created under the Department of Agriculture and Natural Resources an office to be known as the Bureau of Animal Industry.

Section 2. Chief Officials of the Bureau of Animal Industry ? The Bureau of Animal Industry shall have one chief and one assistant chief, to be known respectively as the Director of the Bureau of Animal Industry and Assistant Director of the Bureau of Animal Industry. The Director of the Bureau of Animal Industry and Assistant Director of the Bureau of Animal Industry shall be either a competent veterinary surgeon or a man well trained in animal husbandry. They shall receive compensations at the rates of seven thousand two hundred and six thousand pesos per annum, respectively: Provided, that should any person now in the service of the Government of the Philippine Island receiving a rate of compensation higher than the amount herein authorized be appointed the first Director of the Bureau of Animal Industry, the salary of such Director shall be equal to the total remuneration now being received by him for service rendered in one or more government entities: Provided, however, that the said rate of salary shall not exceed twelve thousand pesos per annum and shall be in effect only as long as the said Director remains in office.

Subject to the general supervision and control of the Secretary of Agriculture and Natural Resources, the Director of the Bureau of Animal Industry shall possess the powers generally conferred upon bureau chiefs.

Section 3. Functions of the Bureau of Animal Industry ? The Bureau of Animal Industry shall investigate, study and report upon:

condition of domestic animals in the Philippine Islands, their improved reproduction and care;

inquire into and report the causes of dangerous communicable diseases among them, and the means for the prevention and cure of the same, and in general,

to promote the development of the livestock industry in the country, as follows:
By the introduction of improved or purebred domestic animals for breeding purposes, and the improvement of the quality of the breeds or types of domestic animals now found in the Islands;
By the control and eradication of dangerous communicable diseases of domestic animals;
By conducting a system of demonstration and extension work and encouraging fairs and exhibitions to promote the livestock industry;
By the collection and compilation of statistics on domestic animals;
By the dissemination of useful information on all essential matters regarding domestic animals through the publication and distribution of bulletins, circulars, and other printed matter, and through other means of agencies as maybe deemed effective, and;
By taking such steps, adopting such measures and promulgating such rules and regulations; not inconsistent with the provisions of this Act and subject to the approval of the Secretary of Agriculture and Natural Resources, as maybe deemed necessary to promote the livestock industry.

Section 4. Terms Defined ?

?Domestic animal? as herein used, includes horses, mules, asses, cattle, carabaos, hogs, sheep, goats, dogs, deer, fowls and circus animals or those intended to be used for show purposes.

?Dangerous communicable diseases? as herein used, include glanders or farcy, surra, anthrax, rinderpest, hemorrhagic septicemia, European Fowl Pest, fowl cholera, fowl typhoid, or any other acute communicable diseases, which may cause a mortality of over 5% in a period of one (1) month.

Section 5. Animal quarantine, Inspection and Importation, Rinderpest Vaccine, Powers and Duties of the Bureau of Animal Industry- The power, functions and duties vested in the Bureau of Agriculture by virtue of the following provisions:

Seventeen hundred and sixty-two (1762) ?Bringing of animals imported from foreign countries into the Philippine Islands?;

Seventeen hundred sixty-three (1763) ?Removal of diseased animals from province to province prohibited?;

Seventeen hundred and sixty-four (1764) ?Regulation concerning removal of diseased animals from infected localities?;

Seventeen hundred and sixty-five (1765) ?Powers and Duties of Animal Industry relative to animal quarantine, inspection and sanitation?;

Seventeen hundred and sixty-six (1766) ?Delivery of diseased animal to place of quarantine?;

Seventeen hundred and sixty-seven (1767) ?Disposition of body of animals dying of rinderpest?;

Seventeen hundred and sixty-eight (1768) ?Unlawful disposition of parts of animals dying of rinderpest?;

Seventeen hundred and sixty-nine (1769)? Marking of cattle afflicted with surra?;

Seventeen hundred and seventy (1770) ?Prohibition against bringing of animals from infected foreign countries? of the Revised Administrative Code of nineteen hundred and seventeen (1917);

by virtue of Acts Numbered thirty-one hundred and one (1301), entitled ?An Act authorizing the Director of Agriculture, subject to the approval of the Secretary of Agriculture and Natural Resources, to promulgate regulations for the preparation, sale, traffic in shipment and importation of viral vaccines, serum, toxins or analogous products used for the treatment of domestic animals, and

thirty-one hundred and sixty-six (3166), entitled ?An Act providing animals for the use of rinderpest vaccine in the control of rinderpest and other contagious and infectious cattle diseases, appropriate the sum of one hundred thousand pesos, and for other purposes, ?and of such acts or parts of acts wherein the intervention of the Bureau of Agriculture is required expressly, or impliedly, in matters concerning domestic animals or their diseases, are hereby transferred to and vested in the Bureau of Animal Industry.

Section 6. Stock Farms, Slaughterhouses and Breeding Stations ? In such places in the Philippine Islands as maybe considered suitable for the purpose, the Director of Animal Industry, with the approval of the Secretary of Agriculture and Natural Resources, shall, as funds become available therefore establish, equip, maintain and operate stock farms, slaughterhouses and breeding stations to produce and develop superior types of domestic animals adapted to local conditions and needs.

Section 7. Transfer of certain divisions to the Bureau of Animal Industry- The Divisions of Animal Industry, comprising the veterinary section, the animal husbandry section, the animal quarantine stations, the veterinary research laboratory, and the stock farms, of the Bureau of Agriculture; the stock farms established under Act Numbered twenty-seven hundred and fifty-eight (1758) and the appropriations therefore and all other governmental agencies connected with these activities, together with their personnel, equipment, implements, materials, properties and other complementary effects, are hereby transferred to the Bureau of Animal Industry. The Director of the Bureau of Animal Industry shall, subject to the approval of the Secretary of Agriculture and Natural Resources, reorganize these activities into such divisions, or sections as well insure the simplest organization and maximum efficiency, and create such other divisions or sections, together with the positions required therein, as maybe deemed necessary for the proper functioning of the said Bureau; Provided, that the Secretary of Agriculture and Natural Resources, may, in the interest of the service, or for reasons of economy, or due to lack of funds, transfer such positions with their respective appropriations from the administrative, clerical, or other non-technical force of the Bureau of Agriculture to the Bureau of Animal Industry as may be urgently needed by the said Bureau of Animal Industry.

Section 8. Bureau of Plant Industry ? The different divisions, sub-divisions, sections, experimental stations, etc., of the Bureau of Agriculture and all activities of agencies connected therewith which have not been transferred by virtue of this Act to the Bureau of Animal Industry, shall collectively, constitute and be known as the Bureau of Plant Industry. The powers, functions, ex-officio positions and duties vested by law or executive order in the Director of Agriculture and the Bureau of Agriculture which have not been transferred to the Bureau of Animal Industry, are hereby vested in and are to be performed by the Director of Plant Industry and the Bureau of Plant Industry. The Chief and Assistant Chief of the said Bureau shall be known respectively as the Director of the Bureau of Plant Industry and Assistant Director of the Bureau of Plant Industry and shall receive the same compensations as that heretofore authorized for the Director and Assistant Director of the Bureau of Agriculture; Provided, that the Director of the Bureau of Plant Industry shall not be paid any additional compensation for services he may render in any government entities.

Section 9. Appropriation -There is hereby appropriated, out of any funds in the Insular Treasury not otherwise appropriated, the sum of twenty thousand pesos which, together with funds appropriated in the General Appropriations Act (GAA) for nineteen hundred and thirty (1930) for the division of animal industry and other activities transferred by this Act from the Bureau of Agriculture to the Bureau of Animal Industry, shall be available for the payment of salaries of the personnel; traveling expenses of personnel, freight, express and delivery service; postal, telegraph, telephone and cable services; illumination and power service; rental of buildings and grounds; consumption of supplies and materials; printing and binding reports, documents and publications; contributions and gratuities; and other services; Provided, That the special appropriations made in the said General Appropriations Act (GAA) for nine hundred and thirty shall be devoted exclusively to the purposes for which they are appropriated: Provided, further, That the Secretary of Agriculture and Natural Resources shall apportion between the Bureau of Animal Industry and the Bureau of Plant Industry the appropriations made for salaries and wages for temporary and emergency employees including laborers and sundry expenses for the Bureau of Agriculture in the GAA for nineteen hundred and thirty (1930).

Section 10. All acts or parts of acts inconsistent with the provisions of this Act are hereby amended or repealed accordingly.

Section 11. This Act shall take effect on January first, nineteen hundred and thirty (1930).

Approved. December 7, 1929.

Republic of the Philippines

Ministry of Agriculture

BUREAU OF ANIMAL INDUSTRY

Manila

PROVISIONS OF THE REVISED ADMINISTRATIVE CODE AFFECTING THE BUREAU OF ANIMAL INDUSTRY

Section 1761. Terms defined - ?Domestic animals,? as herein used, includes horses, mules, cattle, carabaos, hogs, sheep goats, dogs, deer, and circus animals or those intended for show purpose.

?Dangerous communicable disease? as herein used, includes glanders, or farcy, surra, rinderpest, hemorrhagic septicemia, hog cholera, foot-and-mouth disease, contagious pleuropneumonia, or any other acute communicable disease which may case a mortality of over five per centum in the period one month.

Section 1762. Bringing of animals imported from foreign countries into the Philippines. It shall be unlawful for any person or corporation to import, bring or introduce live cattle into the Philippines from any foreign country. The director of Animal Industry may, with approval of the Head of the Department first had authorized the importation, bringing or introduction of various classes of thoroughbred cattle from foreign countries for breeding the same to the native cattle of the Philippines, and such as may be necessary for the improvement of the breed, not to exceed five hundred head per annum; provided, however, that the Director of Animal Industry shall in all cases permit the importation, bringing or introduction of draft cattle and bovine cattle for the manufacture of serum; provided, further, that all live cattle from foreign countries the importation, bringing or introduction of which into the Philippines is authorized by this Act, shall be submitted to regulations issued by the Director of Animal Industry, with the approval of the Head of the Department, prior to authorizing its transfer to other provinces.

At any time of the approval of this Act, the President of the Philippines shall issue regulations in order to provide against a raising of the price both fresh and refrigerated meat. The President of the Philippines also may, by executive order, suspend this prohibition for a fixed period in case local conditions require it.

Section 1763. Removal of diseased animal from province to province prohibited. It shall be unlawful for any person knowingly to ship, drive or otherwise take to transport from one island, province, municipality, or municipal districts to another any domestic animal suffering from any dangerous communicable disease or to expose such animal, either alive or dead to any public road, street, or highway where it may come in contact with other domestic animals.

Section 1764. Regulation concerning removal of diseased animals from infected localities. When the Department Head shall declare that a dangerous communicable disease prevails in any island, province, municipality, or municipal district and that is danger of spreading such disease by shipping, driving, or otherwise, transporting or taking out such island, province, municipality, or municipal district any class of domestic animals, it shall be unlawful for any person, firm, or corporation to ship, drive, or otherwise remove the kind of animals so specified from such locality except when accompanied by a certificate issued by authority to be shipped, driven, taken or transported and their brands and distinguishing marks. Such certificate shall also state that the animals in question have been inspected by a duly authorized agent of the Director of Animal Industry and found free from dangerous communicable diseases and shall give the date of such inspection.

Section 1765. Powers of Director of Animal Industry relative to animal quarantine, inspection and sanitation.

a)To maintain inoculation, quarantine, and detention station for domestic animals in such places as may be approved from time to time by the Department Head, and to place all animals arriving from foreign and domestic parts or interior places in quarantine for such time as he may deem necessary to prevent the introduction and spread of dangerous communicable animal diseases.
b)To inspect all domestic animals arriving, by boat, rail, or otherwise in the cities, ports or places where quarantine stations are maintained in such other places as he may deem necessary for the purpose of preventing the introduction and spread of dangerous communicable animal disease within the Philippines.
c)To require that animals suffering from dangerous communicable diseases or have been exposed thereto be placed in quarantine at such place and for such time as may be deemed by him necessary to prevent the spread of such disease.
d)To require the cleaning and disinfecting of any utensil, place, corral, yard, or building deemed by him to be infected with dangerous communicable diseases, and to prohibit the keeping of any domestic animals in such place, corral, yard or building until it has been placed in a sanitary condition.
e)To require the cleaning and disinfecting of any boat, car, vehicle, or other conveyance deemed by him to be infected with dangerous communicable animal disease, and to prohibit its further use for transporting domestic animals until it have been placed in a sanitary condition.
f)To cooperate with provincial and municipal boards in the suppression of dangerous communicable animal diseases and to supervise and control the establishment and maintenance if municipal meat and milk inspection system, except in matters of sanitation and public health coming under the jurisdiction of the Bureau of Health.

The technical personnel that may be needed for the proper supervision and inspection thereof shall be appointed by the Secretary of Agriculture and Natural Resources upon the recommendation of the Director of Animal Industry, once the position is created by the respective chartered city or municipality, and the renumeration of such personnel and other expenses shall be payable from the meat and milk inspection fees collected by the respective municipalities concerned.

g)To prescribe all necessary measures for the enforcement of the Provisions of subsections c), d) and e) above. The provincial governor of the province concerned shall have the direction of and be responsible for the enforcement of the measures so prescribed.

Section 1766. Delivery of disease animal to place of quarantine. When the Director of Animal Industry shall order any animal to be placed in quarantine under the provision of this article, the owner of such animal, or his agent, shall deliver it at the place designated for the quarantine and shall provide it with proper food, water and attendance. Should the owner or his agent fail to comply with this requirement the Director of Animal Industry may furnish supplies and attendance needed and the reasonable cost of such supplies and attendance shall be collectible from the owner or his agent.

Section 1767. Disposition of body of animal dying of rinderpest. The owners of animals which die having rinderpest shall, where practicable, cause their bodies to be burned and shall inter any unconsumed portions remaining. Where it is impracticable to burn such bodies, they shall cause them to be interred at a depth of at least one meter below into surface of the ground and thoroughly covered with earth.

It shall be unlawful to remove the skin, horns, or any part of the body of an animal which dies having rinderpest, except the bile or blood serum for use in immunizing other animals against the disease, and the removal of such materials shall be effected only by a veterinarian duly authorized by the Director of the Bureau of Animal Industry.

Section 1768. Unlawful disposition of parts of animals dying of rinderpest. It shall be unlawful for any person knowingly to have in his possession, or any other part of an animal which had died having rinderpest, except the bile or blood serum, and all persons having in their possession skins, horns, or other portions of such animals shall destroy them by burning or shall inter them. Officers of the law are hereby authorized to seize and destroy such skins, horns, or other portions of the body of any animal which had died having rinderpest wherever found.

Section 1769. Marking of cattle affected with surra. It shall be lawful for any duly authorized agent of the Bureau of Animal Industry or of the Bureau of Science to mark any animal found to be afflicted with surra by fastening in its right ear a metal tag marked with the letter ?S? and with a number. It shall be unlawful to remove any such tag affixed as provided in this section until the animal so marked has been pronounced free from surra by a duly authorized agent of the Bureau of Animal Industry or of the Bureau of Science.

Section 1770. Prohibition against bringing of animals from infected foreign countries ? When the Department Head shall be general order declare that a dangerous communicable animal disease prevails in any foreign country, port or place and that there is danger of spreading such disease by the importation of domestic animals there from, it shall be unlawful for any person knowingly to ship or bring into the Philippines any such animal. Animal effects, parts, or products from such places, unless the importation thereof shall be authorized under the regulations of the Bureau of Animal Industry.

Section 2747. Violation of provisions relative to animal quarantine. Any person who shall violate any provision of sections one thousand seven hundred and sixty-two to one thousand seven hundred and sixty-five, inclusive, of this Code shall be punished by a fine of not more than one thousand pesos, or by imprisonment for not more than six months, or by both.

Any person who shall violate any provisions of any section or any lawful regulation or order pursuant thereto for which delinquency no specific penalty is provided by law, shall be punished by a fine of not more than one hundred pesos or by imprisonment for not more than thirty days, or both.

Section 2749. Offenses connected with practice of veterinary medicine. Every person who shall unlawfully engage in the practice of veterinary medicine in the Philippines without holding a certificate as veterinarian issued by the Board of Examiners shall be punished for each offense by a fine of not less than twenty-five nor more than six months, or both, in the discretion of the court.

Every person who, with intent to deceive the Board of Veterinary Examiners, present to the same as and for his own any certificate or diploma issue to any fraudulent or spurious certificate or diploma of like characters shall be subject to the same penalty.

An Act To Ensure The Safety And Purity Of Foods,
Drugs And Cosmetics Being Made Available To The Public
By Creating The Food And Drug Administration
Which Shall Administer And Enforce The Laws Pertaining Thereto.

REPUBLIC ACT 3720

AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

CHAPTER I. ? TITLE

Section 1. This Act shall be known as the ?Food, Drug and Cosmetic Act?.

CHAPTER II. ? DECLARATION OF POLICY

Section 2. It is hereby declared the policy of the State to ensure safe and good quality supply of food, drug and cosmetic, and to regulate the production, sale and traffic of the same to protect the health of the people.

Section 3. In the implementation of the foregoing policy, the Government shall in accordance with the provision of this Act:

a. Establish standards and quality measures for food, drug and cosmetic.

b. Adopt measures to insure pure and safe supply of food, drug and cosmetic in the country.

CHAPTER III ? CREATION OF THE FOOD AND DRUG ADMINISTRATION

Section 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration in the Department of Health. Said Administration shall be under the office of the Secretary and shall have the following functions, powers and duties:

a. To administer and supervise the implementation of this Act and of the rules and regulations issued pursuant to the same.

b. To provide for the collection of samples of food, drug and cosmetic.

c. To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act.

d. To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards and to recommend standards of identity, purity, quality and fill of container.

e. To issue certificate of compliance with technical requirements to serve as basis for the issuance of license and spot-check for compliance with regulations regarding operation of food, drug and cosmetic manufacturer and establishment.

f. To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the provisions of this Act.

g. To certify batches of antibiotic and antibiotic preparations in compliance with the provisions of this Act.

Section 5. The Food and Drug Administration shall have the following Divisions:

a. Inspection and Licensing Division, which shall have charge of the inspection of food, drug and cosmetic establishment engaged in their manufacture and sale.

b. Laboratory Division, which shall conduct all the tests, analyses and trials of products covered by this Act.

Section 6. The Food and Drug Administration shall have a Food and Drug Administrator who shall be appointed by the Secretary of Health subject to the Civil Service rules and regulations. The compensation of said official shall be determined by the Secretary of Health.

Section 7. The Secretary of Health shall provide for the additional personnel needed to carry out the functions and duties of the Food and Drug Administration.

Section 8. The powers, functions and duties of the Divisions of Food and Drug Testing and the Bureau of Research Laboratories and the Board of Food Inspection, all personnel in the Bureau of Health Services who are engaged in food and drug control work, together with all their equipment, supplies, records, files, personnel and balance of appropriations are transferred to the Food and Drug Administration.

CHAPTER IV. BOARD OF FOOD AND DRUG INSPECTION

Section 9. The Board of Food Inspection is hereby converted into the Board of Food and Drug Inspection of Health who shall consist of:

(a) A representative of the Department of Health to be designated by the Secretary of Health, as Chairman;

(b) A representative of the Department of Agriculture and Natural Resources;

(d) An authorized designate of the Commissioner of Customs;

(e) An authorized representative of the Office of the Solicitor General;

(f) A technical member to be designated by the Food and Drug Administrator with the approval of the secretary of Health;

(g) The President of the Philippine Medical Association or his authorized representative;

(h) The President of the Philippine Dental Association or his authorized representative;

(i) The President of the Philippine Pharmaceutical Association or his authorized representative;

Each member of the Board, as well as the Board Secretary, shall receive a per diem of twenty pesos per meeting, hearing or investigation actually attended, but in no case shall the total per diem exceed two hundred pesos each per month.

It shall be the duty of the Board, conformably with the rules and regulations, to hold hearing and conduct investigations relative to matters touching the administration of this Act, to investigate processes of food, drug and cosmetic manufacture and to submit reports to the Food and Drug Administrator, recommending food and drug standards for adoption. Said Board shall also perform such additional functions, properly within the scope of the administration hereof, as maybe assigned to it by the Food and Drug Administrator. The decisions of the Board shall be advisory to the Food and Drug Administrator.

CHAPTER V. DEFINITIONS

Section 10. For the purposes of this Act. The terms:

(a) ?Board? means the Board of Food and Drug Inspection;

(b) ?Secretary? means the Secretary of Health;

(d) ?Food? means (1) articles used for food and drink for man, (2) chewing gum, and (3) articles used for components of any such article;

(e) ?Person? includes individual partnerships, corporations and association;

(f) ?Drug? means

(1) articles recognized by the United States Pharmacopoeia or official National Formulary, or any supplement to any of them;

(2) articles intended for use in the diagnosis, care, mitigation, treatment or prevention of diseases in man or other animals; and

(3) articles (other than food) intended to affect the structure or any function of the body of man or animals; and

(4) articles intended for use as a component of any articles specified in clauses (1), (2) and (3), but does not include devices or their components, parts or accessories;

(g) ?Device? means instrument, apparatus, or contrivances, including their components, parts, and accessories, intended for (1) for use in the diagnosis, cure, mitigation, treatment or prevention of diseases in man or animals; or (20 to affect the structure or any function of the body of man and animals;

(h) ?Cosmetic: means (1) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for as a component of any such articles;

(i) ?Label? means a display of written, printed or graphic matter upon the immediate container of any article and a requirement made by or under authority of this Act that any word, statement or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

(j) ?Immediate container? does not include package liners.

(k) ?Labeling? means all labels and other written, printed or graphic matter (1) upon articles or in any of its containers or wrappers, or (2) accompanying such article.

(l) ?New drugs? mean:

1. Any drug the composition of which is such that said drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof.

2. Any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(m) If an article is alleged to be misbranded because the labeling is misleading, therein determining whether the labeling is misleading there shall be taken (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such consequences which may result from the use of the article to which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such

(n) ?Food additive? means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use, if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedure to be safe under the conditions of the intended use.

CHAPTER VI ? PROHIBITED ACTS AND PENALTIES

Section 11. The following acts and the causing thereof are hereby prohibited:

(a) The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device or cosmetic.

(d) The giving of a guaranty or undertaking referred to in Section 12 (b) hereof, which guarantee or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the Philippines from whom he received in good faith the food, drug, device or cosmetic or the giving of a guaranty or undertaking referred to in Section 12 (b) which guaranty or undertaking is false.

(e) Forging, counterfeiting, simulating or falsely representing or without proper authority using any mark, stamp, tag label or other identification device authorized or required by regulations promulgated under the provisions of this Act.

(f) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant to any judicial proceedings under this Act, any information acquired under authority of Section 9, or concerning any method or process which as a trade secret is entitled to protection.

(g) The alteration, mutilation, destruction, obliteration, removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device or cosmetic, if such is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded.

(h) The use, on the labeling of any drug or in any advertising relating to such drug, or any representation or suggestion that an application with respect to such drug is effective under Section 21 hereof, or that such drug complies with the provisions of such section.

PENALTIES

Section 12.

(a) Any person who violates any of the provisions of Section 11 hereof, shall, upon conviction, be subject to imprisonment of not less than six months and one day, but not more than five years, or a fine of not less than one thousand pesos, or both such imprisonment and fine, in the discretion of the court.

(b) No person shall be subject to the penalties of subsection (a) of this section (1) for having sold, offered for sale or transferred any article and delivered it, if such delivery was made in good faith, unless he refuses to furnish on request of the Board of Food and Drug Inspection or an officer or employee duly designated by the Secretary, the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; (2) for having violated Section 11 (a) if he established a guaranty or undertaking signed by, and containing the name and address of the persons residing in the Philippines from whom he received in good faith the article, or (3) for having violated the Section 11 (a), where the violation exists because the article is adulterated by reason of containing a coal-tar color nor permissible under regulations promulgated by the Secretary under this Act, if such person establishes a guaranty or undertaking signed by, and containing the name and address of the manufacturer of the coal tar color, to the effect that such color is permissible, under applicable regulations promulgated by the Secretary under this Act.

(c) Any article of food, drug, device or cosmetic that is adulterated or misbranded when introduced into the domestic commerce maybe seized and held in custody pending proceedings pursuant to Section 26 (d) hereof, without a hearing or court order, when the Secretary has probable cause to believe from facts found by him or any officer or employee of the Food and Drug Administration that the misbranded article is dangerous to health, or that the labeling of the misbranded articles is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer.

CHAPTER VII. DEFINITIONS AND STANDARDS FOR FOOD

Section 13. Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall, upon recommendation of the Food and Drug Administrator, promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standard of fill of container: Provided, that no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables.

ADULTERATED FOOD

Section 14. A food shall be deemed to be adulterated:

A. (1) If it bears or contains any poisonous or deleterious substances which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

(2) If it bears or contains any added poisonous or added deleterious substance other than one which is a pesticide chemical in or on a raw agricultural commodity for which tolerances have been established and it conforms to such tolerances;

(3) If it consists in whole or in part of any filthy, putrid or decomposed substance, or if it is otherwise unfit for food;

(4) If it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(5) If it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter;

(6) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

B. (1) If any valuable constituent has been, in whole or in part, omitted or abstracted there from and same has not been substituted by any healthful equivalent of such constituent;

(2) If any substance injurious to health has been added or substituted;

(3) If damage or inferiority has been concealed in any manner; and

(4) If any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than what it is.

C. If it bears or contains a coal-tar color other than on which is permissible under existing regulations.

D. If it is confectionary, and it bears or contains any alcohol or non-nutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glass not in excess of four-tenths of one percentum natural gum and pectin: Provided, That this paragraph shall not apply to any confectionary by reason of its containing less than one-half of one percentum by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless non-nutritive masticatory substances;

E. If it is oleomargarine or margarine or butter or any of the raw material used therein, which consists of, in whole or in part, of any filthy, putrid or decomposed substance, or such oleomargarine, margarine or butter is otherwise unfit for food.

MISBRANDED FOOD

Section 15. A food shall be deemed misbranded:

A. If it s labeling is false or misleading in any particular;

B. If it is offered for sale under the name of another food;

C. If it is an imitation of another food, unless its label bears in type of uniform size and prominence, the word ?imitation? and, immediately thereafter the name of the food imitated;

D. If its container is so made, formed, or filled as to be misleading;

E. If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, numerical count: ?Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small package shall be established, by regulations prescribed by the Secretary.

F. If any word, statement, or other information required by or under authority of the Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words. Statements, designs or devices, in the labeling), and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

G. If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed unless (1) it conforms to such definition and standards, and (2) its label bears the name of the food specified in the definition and standard, and insofar as maybe required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

H. If it purports to be or is represented as-

(1) A food for which a standard of quality has been prescribed by regulations as provided by Section 13 and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard.

(2) A food for which a standard or standards of fill of container have been prescribed by regulations as provided by Section 13 and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, statement that it falls below such standard.

I. If it is not subject to the provisions of paragraph G of this Section unless its label bears

(1) the common or usual name of the food, if there be any, and

(2) in case it is fabricated from two or more ingredients, the common or usual name of such ingredient; except that spices, flavorings and colorings, other than those sold as such, maybe designated as spices, flavorings and colorings without naming such: Provided, That to the extent that compliance with the requirements of clause (2) of this paragraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

J. If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral and other dietary properties as the secretary determine to be, and by regulations prescribed as necessary in order fully to inform purchasers as to its value for such uses.

K. If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. The provisions of this paragraph or paragraphs (G) and (I) with respect to artificial coloring shall not apply in the case of butter, cheese or ice cream.

EMERGENCY PERMIT CONTROL

Section 16. (a) Whenever the Secretary finds after investigation that the sale or distribution in domestic commerce of any class of food may be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered domestic commerce, he shall promulgate regulations also in accordance with the recommendations of the Food and Drug Administrator providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, or permits to which shall be attached such conditions governing the manufacture, processing or packing of such class of food, for such temporary period of time, as maybe necessary to protect the public health; and after the effective date of such regulations and during such temporary period, no person shall manufacture, sell or offer for sale or transfer any such food manufactured, processed or packed by any such manufacturer, processor or packer unless such manufacturer, processor or packer holds a permit issued by the Secretary as provided by such regulations.

(b) The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated.

(c) Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

Tolerances for Poisonous Ingredients in Food

COAL TAR COLOR FOR FOOD

Section 17. (a) Any poisonous or deleterious substance added to any food, shall be deemed to be unsafe except when such substances is required or can not be avoided in its production or manufacture. In such case, the Secretary shall promulgate, upon recommendation of the Food and Drug Administrator, regulations limiting the quantity therein to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe. In determining the quantity of such substances to be tolerated in different articles of food, the Secretary shall take into account the extent to which the use of such article is required or can not be avoided in the production or manufacture of such article and the other ways in which the consumer maybe affected by the same or other poisonous or deleterious substances.

(b) The Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations providing for the listing of coal tar which is harmless and suitable for use in food.

CHAPTER VIII. DRUGS AND DEVICES

ADULTERATED DRUGS AND DEVICE

Section 18. A drug or device shall be deemed to be adulterated:

A. (1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or

(2) If its has been prepared, packed or held under unsanitary conditions contaminated with filth or whereby it may have been rendered injurious to health; or

(3) If it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(4) If it is a drug and it bears or contains, for purposes of coloring only, a coal tar other than a permissible one.

B. If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium, except that whenever tests or methods of assay as are prescribed are, in the judgment of the Secretary insufficient for the making of such determination the Secretary shall promulgate, upon recommendation of the Food and Drug Administrator, regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality or purity therefore set forth in such compendium, if its difference in strength, quality or purity from such standards is plainly stated on its label.

C. If it is not subject to the provisions of paragraph (B) of this section and its strength differs from, or its purity or quality falls bellow, that which it purports or is represented to possess.

D. If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefore.

MISBRANDED DRUGS AND DEVICES

Section 19. A drug or device shall be deemed to be misbranded:

A. If its labeling is false or misleading in particular.

B. If in a package form unless it bears a label containing:

(1) the name and place of business of the manufacturer, packer, or distributor;

(2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count: Provided, That reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary.

C. If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

D. If it is for use by man and contains any quantity of the narcotic or hypnotic substances alphaueaine, bromal, cannabis, chlomal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote or sulfomethane; or any chemical derivatives of such substance, which derivative has been recommended by the Secretary, after investigation, and by regulations designated as, habit forming; unless its label bears the name, and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement ?Warning- maybe habit-forming?.

E. If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears

(1) the common or usual name of the drug, if such there be; and

(2) in case it is fabricated from two or more ingredient, including the quantity, kind and proportion of any alcohol and also including whether active or not, the name and quality of proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyanamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophantin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, That where compliance with this paragraph is impracticable exemptions shall, upon recommendation of the Food and Drug Administrator, be established by regulations promulgated by the Secretary.

F. Unless its label bears

(1) Adequate direction for use; and

(2) Such adequate warnings against use in those pathological conditions or by children where its use maybe dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: Provided, That where any requirements of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of public health, the Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations of exempting such drug or device from such requirement.

G. If it purports to be a drug the name of which is recognized in an official compendium unless it is packaged and labeled as prescribed therein: Provided, That the method of packing maybe modified with the consent of the Secretary.

H. If it has been found by the Secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health.

I. (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or

(2) If it is an imitation of another drug; or

(3) If it is offered for sale under the name of another drug.

J. If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof.

K. If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof unless

(1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section 22 (1) and;

(2) such certificate of release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class exempted by regulations promulgated under Section 21 (a), (b) and (c).

EXEMPTION IN CASE OF DRUGS AND DEVICES

Section 20. (a) The Secretary is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this Act drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded, under the provisions of this Act upon removal from such processing, labeling or repacking establishment.

(b) 1. Drugs intended for use by man which:

A. are habit-forming

B. because of its toxicity or other potentiality for harmful effect, or the method of its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.

C. are new drugs whose application are limited to investigational use shall be dispensed only upon (1) a written prescription of a practitioner licensed by law to administer such drug, or (2) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by an oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which result in the drug being misbranded while held for sale.

1. Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section 19, except paragraphs (a), (1), (2) and (3), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of prescriber, and if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription.

2. The Secretary may by regulation remove drugs subject to Section 19 (d) and Section 21 from the requirements of Subsection (b) (1) of this Section, when such requirements are not necessary for the protection of public health.

3. A drug which is subject to Subsection (b) (1) of this Section shall be deemed to be misbranded if at any time prior to dispensing, its label fails to bear the statement ?Caution: Food, Drug and Cosmetic Law prohibits dispensing without prescription?. A drug to which Subsection (b) (1) of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.

NEW DRUGS

Section 21. (a) No person shall manufacture, sell, offer for sale or transfer any new drug, unless an application filed pursuant to Subsection (b) is effective with respect to such drug.

(b) Any person may file with the Secretary, thru the Food and Drug Administration, an application with respect to any drug subject to the provisions of Subsection (a). Such persons shall submit to the Secretary thru the Food and Drug Administration, as a part of the application

1. full reports of investigations which have been made to show whether or not such drug is safe for use;

2. a full list of the articles used as components of such drug;

3. a full statement of the composition of such drug;

4. a full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug;

5. Such samples of such drug and of the article used as components thereof as the Secretary may require; and

6. Specimens of the labeling proposed to be used for such drug.

(c) Within one hundred and eighty (180) days after the filing of an application under this subsection or such additional period as maybe agreed upon by the Secretary and the applicant, the Secretary shall either (1) approve the application if he finds that none of the grounds for denying approval specified in Subsection (d) applies, or (2) give the applicant notice of an opportunity for a hearing before the Secretary under Subsection (d) on the question whether such application is approvable.

(d) If the Secretary finds, after due notice to the applicant and giving him an opportunity for a hearing, that

(1) the investigations, reports of which are required to be submitted to the Secretary pursuant to Subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;

(2) the results of such test show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;

(3) the methods used in, and the facilities and controls used for the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; or

(4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or

(5) evaluated on the basis of the information submitted to him as part of the application, and any other information before him with respect to such drug, there is lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended or suggested in the proposed labeling thereof; or

(6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he (the Secretary) shall issue an order refusing to approve the application.

(e) The effectiveness of an application with respect to any drug shall, after due notice and opportunity for hearing to the applicant, by order of the Secretary be suspended if the Secretary finds:

(1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such application became effective show that such drug is unsafe for use under the conditions of use upon the basis of which the application became effective; or

(2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it is based.

(f) An order refusing to permit an application with respect to any drug to become effective shall be revoked whenever the Secretary finds that the facts so require.

(g) The Secretary shall promulgate regulations for exempting from the operation of the Section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.

CHAPTER IX ? CERTIFICATION OF DRUGS CONTAINING PENICILLIN, STREPTOMYCIN, CHLORTETRACYCLINE, CHLORAMPHENICOL OR BACITRACIN

Section 22. (a) The Secretary, pursuant to regulations promulgated by him shall provide for the certification of batches or drugs composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof. A batch of such drug shall be certified if such drug has such characteristics for identity, strength, quality and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release of any batch which, in his judgment, maybe released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. For purposes of this Section and of Section 19 (k), the term ?antibiotic drug? means any drug intended for use by man containing any quantity of any chemical substance which is produced by microorganisms and which has the capacity to inhibit or destroy microorganisms in dilute solutions (including the chemically synthesized equivalent of any such substance).

(b) Whenever in the judgment of the Secretary, the requirements of this Section and of Section 19 (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use, the Secretary shall promulgate regulations exempting such drug or class of drugs from such existing requirements.

(1) drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirement upon removal from such establishments;

(2) drugs which conform to applicable standards of identity, strength, quality and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and

(3) drugs which are intended for investigations use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs.

CHAPTER X ? COSMETICS

Section 24. A cosmetic shall be deemed to be misbranded:

(a) If it?s labeling is false or misleading in particular.

(b) If in package form unless it bears a label containing

(1) the name and place of business of the manufacturer, packer, or distributor; and

(2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical counts: Provided, That under reasonable causes, variations shall be permitted and exemptions as to small package shall be established, by regulations prescribed by the Secretary.

(c) If any word, statement, or other information required by or under authority of this Act, to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) If its container is so made, formed or filled as to be misleading.

REGULATIONS MAKING EXEMPTIONS

Section 25. The Secretary shall promulgate regulations exempting from any labeling requirements of this Act, cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act when removed from such processing, labeling or repacking establishment.

CHAPTER XI ? GENERAL ADMINISTRATION, PROVISION, REGULATION, HEARING and INSTITUTION OF CRIMINAL ACTION

Section 26. (a) Except as otherwise provided in this Section, the Secretary of Health shall, upon recommendation of the Food and Drug Administrator, issue rules and regulations as maybe necessary to enforce effectively the provisions of this Act.

(b) The Commissioner of Customs, the Commissioner of Internal Revenue and the Secretary of Health shall jointly prescribe regulations for the efficient enforcement of the provisions of the provisions of Section 30, except as otherwise provided therein. Such regulations shall be promulgated upon the recommendation of the Food and Drug Administrator and shall take effect at such time, after due notice, as the Secretary of Health shall determine.

(c) Hearing authorized or required by this Act shall be conducted by the Board of Food and Drug Inspection which shall submit its recommendation to the Food and Drug Administrator.

(d) When it appears to the Food and Drug Administrator from the report of the Food and Drug Laboratory any article for food or any drug, or cosmetic secured pursuant to Section 28 of this Act is adulterated or misbranded, he shall cause notice thereof to be given to the persons concerned and such person or persons shall be given an opportunity to be heard by the Board of Food and Drug Inspection and to submit evidence impeaching the correctness of the findings or charge in question.

(e) When a violation of any provisions of this Act comes to the knowledge of the Food and Drug Administrator of such character that a criminal prosecution ought to be instituted against the offender, he shall certify the facts to the Secretary of Justice through the Secretary of Health, together with the chemist?s report, the findings of the Board of Food and Drug Inspection, with other documentary evidence on which the charge is based.

(f) Nothing in this Act shall be construed as requiring the Food and Drug Administrator to certify for prosecution pursuant to sub-paragraph (e) hereof, minor violation of this Act whenever he believes that public interest will be adequately served by a suitable written notice or warning.

FACTORY INSPECTION

Section 27. (a) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate credentials to the owner, operator, or agent in charges are authorized (1) to enter, at reasonable hours, any factory, warehouse, or establishment in which food, drugs, devices or cosmetics are manufactured, processed, packed, or held, for introduction in domestic commerce or are held after such introduction, or to enter any vehicle being used to transport or held such food, drugs, devices, or cosmetic factory, warehouse, establishment, or vehicles and all pertinent equipment, finished or unfinished materials, containers, and labeling therein.

Section 28. (a) If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained.

(b) Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purposes of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or in otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator or agent in charge.

PUBLICITY

Section 29. (a) The Secretary may cause to be disseminated information regarding food, drugs, devices, or cosmetics, in situations involving, in the opinion of the Secretary, imminent danger to health, on gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.

CHAPTER XII ? IMPORTS and EXPORTS

Section 30. (a) The Commissioner of Customs shall cause to be delivered to the Food and Drug Administration samples taken at random from every incoming shipment of food, drugs, devices, and cosmetics which are being imported or offended for import into the Philippines giving notice thereof of the owner of consignee. The quantity of such samples shall be fixed by regulation issued by the Secretary. If it appears from the examination of such samples or otherwise that:

(1) such article has been manufactured, processed or packed under unsanitary conditions, or

(2) such article is forbidden or restricted from sale in the country in which it was produced or from which it was exported, or

(3) such article is adulterated, misbranded or in violation of Section 21, then the Food and Drug Administrator shall so inform the Commissioner of Customs and such articles shall be refused admission, except as provided for by subsection (b) of this section. The Commissioner of Customs shall then cause the destruction of any such article refused admission unless such article is exported, under regulation prescribed by the Commissioner of Customs, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. If the food, drug, devices, and cosmetics being imported or offered fro import into the Philippines arrives at a port of entry other than Manila, the collection of such samples shall be the responsibility of the Regional Health Director having jurisdiction over the port of entry and such samples shall be forwarded to the Food and Drug Administration.

(b) Pending decision as to the admission of an article being imported or offered for import, the Commissioner of Customs may authorize delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as maybe required pursuant to regulations of the Commissioner of Customs. If it appears to the Secretary that an article included within the provisions of clause (3) of subsection (a) of this section can, by re-labeling or other action be brought into compliance with the Act or rendered other than a food, drug, device or cosmetic, final determination as to admission of such article maybe deferred, and upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant to perform such re-labeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles or portions thereof as maybe specified in the Secretary?s authorization). All such re-labeling or other action pursuant to such authorization shall be in accordance with regulations and be under the supervision of an officer or an employee of the Bureau of Customs designated by the Commissioner of Customs and a duly authorized representative of the Food and Drug Administrator.

(c) All expenses (including travel per diem or subsistence, and salaries of officers or employees of the Philippines in connection with the destruction provided for in subsection (a) of this section and the supervision of the re-labeling or other action authorized under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cargo, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee, and in default of such payment, shall constitute a lien against any future importation made by such owner or consignee.

(d) A food, drug, device or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it

(1) conforms with the specification of the purchaser,

(2) is not in conflict with laws of the country to which it is intended for export, and

(3) is labeled on the outside of the shipping package to show that it is intended for export.

But if such article is sold or offered for sale in domestic commerce this subsection shall not exempt it from any provisions of this Act.

CHAPTER XIII- FINANCING

Section 31. The amount of one million pesos is hereby appropriated from any funds in the National Treasury not otherwise appropriated to augment the funds transferred to this Office under Section 8 for the implementation of this Act. All income derived from fees authorized in Section 4 of this Act shall accrue to the General Fund.

CHAPTER XIV ? REPEALING CLAUSE and EFFECTIVITY

Section 32. If any provision of this Act or the application of such provisions to any person or circumstance is held invalid, the remainder of this Act of the application of such provision to other persons or circumstances should not be affected thereby.

Section 33. Section eleven hundred and nine to section eleven hundred twenty of the Administrative Code, and such other laws, executive orders, rules and regulations inconsistent with the provisions of this Act are repealed.

Section 34. This Act shall take effect upon its approval.

Approved: June 22, 1963

An Act To Promote, Require And Ensure The Production
Of An Adequate Supply, Distribution, Use
And Acceptance Of Drugs And Medicines Identified
By Their Generic Names.

REPUBLIC ACT NO. 6675

AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1. Title. ? This Act shall be known as the Generics Act of 1988.

Section 2. Statement of Policy. ? It is hereby declared the policy of the State:

To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs;

To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients;

To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution;

To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness; and

To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions.

Section 3. Definition of Terms. ? The following terms are herein defined for purpose of this Act:

(1) ?Generic Name or Generic Terminology? is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic names as determined by the Bureau of Food and Drugs of the Department of Health.

(2) ?Active Ingredient? is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.

(3) ?Chemical Name? is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound.

(4) ?Drug Product? is the finished product from that contains the active ingredient, generally but not necessarily in association with inactive ingredients.

(5) ?Drug Establishment? is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines.

(6) ?Drug Outlets? means drugstores, pharmacies and any other business establishments which sell drugs or medicines.

(7) ?Essential Drug List? or ?National Drug Formulary? is a list of drugs prepared and periodically updated by the Department of Health on the basis of health condition obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complementary list.

(8) ?Core List? is a list of drugs that meets the health care needs of the majority of the population.

(9) ?Complimentary List? is a list of alternative drugs used when there is no response to the core essential drug or when there is a hypersensitivity reaction to the core essential drug or when, for one reason or another, the core essential drug cannot be given.

(10) ?Brand Name? is the proprietary name given by the manufacturer to distinguish its product from those of competitors.

(11) ?Generic Drugs? are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or generic name.

Section 4. The Use of Generic Terminology for Essential Drugs and Promotional Incentives. ? (a) In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared with one hundred eighty (180) days from approval of this Act and updated quarterly by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria.

(b) The exclusive use of generic terminology in the manufacture, marketing and sales of drugs and medicines, particularly those in the Essential Drugs List, shall be promoted through such a system of incentives as the Board of Investments jointly with Department of Health and other government agencies as may be authorized by law shall promulgate in accordance with existing laws, within one hundred eighty (180) days after approval of this Act.

Section 5. Posting and Publication. ? The Department of Health shall publish annually in at least two (2) newspapers of general circulation in the Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the Philippines.

Section 6. Who Shall Use Generic Terminology. ? (a) All government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines.

(b) All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name. The brand name may be included if so desired.

(c) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. In the case of brand name products, the generic name shall appear prominently and immediately above the brand name in all product labels as well as in advertising and other promotional materials.

(d) Drug outlets, including drugstores, hospitals and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products having the same generic name together with their corresponding prices so that the buyer may adequately exercise his option. Within one (1) year after approval of this Act, the drug outlets referred to herein, shall post in conspicuous places in their establishments, a list of drug products with the same generic name and their corresponding prices.

Section 7. Provision on Quality, Manufacturer?s Identity and Responsibility. ? In order to assure responsibility for drug quality in all instances, the label of all drugs and medicines shall have the following name and country of manufacturer, dates of manufacture and expiration. The quality of such generically labeled drugs and medicines shall be duly certified by the Department of Health.

Section 8. Required Production. ? Subject to the rules and regulations promulgated by the Secretary of Health, every drug manufacturing company operating in the Philippines shall be required to produce, distribute and make available to the general public the medicine it produces, in the form of generic drugs.

Section 9. Rules and Regulations. ? The implementation of the provisions of this Act shall be in accordance with the rules and regulations to be promulgated by the Department of Health. Rules and regulations with penal sanctions shall be promulgated within one hundred eight (180) days after approval of this Act and shall take effect fifteen (15) days after publication in the Official Gazette or in two (2) newspapers of general circulation.

Section 10. Authority to Import. ? Within three (3) years from the effectivity of this Act, extendible by the President for another two (2) years and during periods of critical shortage and absolute necessity, the Department of Health is hereby authorized to import raw materials of which there is a shortage for the use of Filipino-owned or controlled or controlled drug establishments to be marketed and sold exclusively under generic nomenclature. The President may authorize the importation of raw materials tax and duty-free. The Secretary of Health shall ensure that the imported raw materials are allocated fairly and efficiently among Filipino-owned or controlled drug establishments. He shall submit to the Office of the President and to Congress a quarterly report on the quantity, kind and value of the raw materials imported.

Section 11. Education Drive. ? The Department of Health jointly with the Department of Education, Culture and Sports, Philippine Information Agency and the Department of Local Government shall conduct a continuous information campaign for the public and a continuing education and training for the medical and allied medical professions on drugs with generic names as an alternative of equal efficacy to the more expensive brand name drugs. Such educational campaign shall include information on the illnesses or symptoms which each generically named drug is supposed to cure or alleviate, as well as its contraindications. The Department of Health with the assistance of the Department of Local Government and the Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress.

Section 12. Penalty. (A) Any person who shall violate Section 6 (a) or 6 (b) of this Act shall suffer the penalty graduated hereunder, viz:

(a) for the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the Professional Regulation Commission.

(b) for the second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000.00) but not exceeding five thousand pesos (P5,000.00) at the discretion of the court.

(c) for the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000.00) but not exceeding the thousand pesos (P10,000.00) and suspension of his license to practice his profession for thirty (30) days at the discretion of the court.

(d) for the fourth and subsequent conviction, the penalty of fine of not less than ten thousand pesos (P10,000.00) and suspension of his license to practice his profession for one year or longer at the discretion of the court.

(B) Any juridical person violates Section 6 (c), 6 (d), 7 or 8 shall suffer the penalty of a fine of not les than five thousand pesos (P5,000.00) nor more than ten thousand pesos (P10,000.00) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the Court: Provided, That its officers directly responsible for the violation shall suffer the penalty of fine and suspension or revocation of license to practice profession if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year or both fine and imprisonment at the discretion of the Court; and Provided, further. That if the guilty party is an alien, he shall be ipso facto deported after service of sentence without need or further proceedings.

(C) The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of license to operate or recommend suspension of license to practice profession to the Professional Regulation Commission as the case may be for the violation of this Act.

Section 13. Separability Clause. - If any provision of this Act is declared invalid, the remainder or any provision hereof not affected thereby shall remain in force and effect.

Section 14. Repealing Clause. ? The provisions of any law, executive order, presidential decree or other issuances inconsistent with this Act are hereby repealed or modified accordingly.

Section 15. Effectivity ? This Act shall take effect fifteen (15) days after its complete publication in the Official Gazette or two (2) newspapers of general circulation.

Approved, September 13, 1988.

Done in the City of Manila, this 27^th day of February in the year of Our Lord, nineteen hundred and eighty-seven.

Rules And Regulations Implementing Republic Act 8203,
Otherwise Known As The Special Law On Counterfeit Drugs

RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT 8203,

OTHERWISE KNOWN AS THE SPECIAL LAW ON COUNTERFEIT DRUGS

AUTHORITY

Pursuant to Section 11 of RA 8203, otherwise known as the Special Law on Counterfeit Drugs, the following rules and regulations are hereby promulgated and consultation of the Secretary of Health.

RULE I. INTERPRETATION AND DEFINITION OF TERMS

Section 1. Short Title. These rules and regulations shall be cited as ?IRR of RA 8203?.

Section 2. Construction. The words and phrases used in these rules shall be interpreted to give meaning to the provisions of RA 8203 in order to safeguard the health of the people and to protect them from counterfeit drugs.

?Bureau or BFAD?? shall refer Bureau of Food and Drugs
?Constructive Knowledge?as herein applied shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he or she has sold, is selling or in possession of is counterfeit, such as, but not limited to the knowledge, that the drug was not covered by any sales invoice or evidence of delivery or purchase from a BFAD licensed drug establishment.
?FDRO?shall mean the Food and DRUG regulation Officer.
?LICD?shall mean Legal, Information and Compliance Division of the BFAD
?Life-saving drugs? shall refer to drug products indicated for life-threatening condition(s).
?LSD? shall mean Laboratory Services Division of the BFAD.
?PSD? shall mean Product Services Division of the BFAD
?Unregistered hospital drug product?? as distinguished from counterfeit drug defined under Section 3 of RA 8203 shall refer to unregistered imported drug product without a registered counterfeit brand in the Philippines. If the unregistered imported drug product has a registered counterpart brand in the Philippines, their product shall be considered counterfeit.

RULE II. PROHIBITED ACTS

Section 1. Prohibited Acts. The acts prohibited or declared unlawful under Section 4 of RA 8203 are adopted as same acts that are prohibited by these rules and therefore punishable by the administrative sanctions herein prescribed.

The following acts are declared unlawful and therefore prohibited:

The manufacture, sale or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation of counterfeit drugs.

Possession of counterfeit drugs.

Forging, counterfeiting, simulating or falsely representing or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized by RA 3720 as amended, and /or regulations promulgated under RA 8203.

Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label or any part thereof, lawfully belonging to another person, for the purpose of using such label or a part hereof.

Making, selling or concealing any punch, dye, plate or any other equipment or instrument designed to print imprint or reproduce the trademark, trade name or other identifying mark of another registered product or any likeness thereof,upon any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade name.

Section 2. Parties Liable. The parties who are liable under Section 5 of RA 8203 are likewise made liable under these rules. These include the following:

The manufacturer, exporter or importer of the counterfeit drugs and their agents: Provided, that the agents shall be liable only upon proof of actual or constructive knowledge that the drugs are counterfeit.

The seller, distributor, trafficker, broker or donor and their agents, upon proof of actual or constructive knowledge that the drugs sold, distributed, offered or donated are counterfeit.

The possessor of counterfeit drugs.

The manager, operator or laboratory facilities used in the manufacture of counterfeit drugs.

The owner, proprietor, administrator, or manager of the drugstore, hospital, pharmacy or dispensary, laboratory or other outlets or premises where the counterfeit drug is found who induces, causes or allows the commission of any prohibited act;

The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells or dispenses such drug to a third party and who shall have actual or constructive knowledge that said drug is counterfeit.

Should the offense be committed by a juridical person, the president, general manager, the managing partner, chief operating officer or the person who directly induces, causes or knowingly allows the commission of the offense shall be penalized.

RULE III. MONITORING OF COUNTERFEIT DRUGS

Section 1. Procedure for Monitoring Counterfeit Drugs in the Market.

The Food and Drug Regulation Officers (FDRO?S) in the course of their inspection of a factory, warehouse, establishment or vehicle, finished or raw materials, containers and labeling therein upon the authority conferred by Section 27 of RA 8203 as amended, shall further determine during such inspection, whether the drug products therein found are counterfeit or not. For the effective implementation of RA 8203, the said inspection shall be without prior notice in any place within the Philippines to prevent the parties liable from concealing them and avoiding inspection.

If upon such inspection, the FDRO shall suspect certain stocks as counterfeit drugs, the FDRO shall conduct an inventory, segregate and seal the suspected stocks, and collect samples for examination as to the products? genuineness and authenticity.

The FDRO shall require the owner or the representative of the inspected establishment or outlet to produce the sales invoice, delivery receipts or documents covering the suspected counterfeit drugs. The FDRO shall only acknowledge and recognize invoices or documents that have been issued by a BFAD licensed manufacturer, trader, distributor, wholesaler or importer with the lot number and expiry date of the drug product(s) indicated herein.

Immediately upon return to his/her office, the FDRO concerned shall submit the samples to either the LSD or PSD for their examination or evaluation. The examination or evaluation shall be for the purpose of determining the authenticity and/or genuineness of the said samples.

Section 2. Duration in the Conduct of Examination. The BFAD shall have twenty (20) working days to determine the genuineness and authenticity of the product.

Section 3. When There is No Need for Laboratory Testing. When the genuineness of the product can be determined by the mere physical examination of the product or the labeling thereof, the PSD shall conduct the examination or evaluation of the same. The result of the physical examination shall be reduced into a certificate of findings.

The Regulation Division I may also require the registered-brand owner of the suspected counterfeit drug to certify whether or not the suspected drug product has been manufactured, imported and/or distributed by them; or whether they own the Lot Number and Expiry Date of the same suspected drug product. The certification issued by the registered brand-owner shall be supported by the batch, production and distribution records. However, the brand-owner?s certification shall be validated by the PSD for evidentiary purposes.

Section 4. When to Refer to LICD for Investigation. When the result of examination shall confirm the suspicion of the FDRO that in fact the drug product is counterfeit, the LSD or PSD shall forward the result of examination to the LICD for a motu proprio investigation. Otherwise, the result of the examination shall be released to the Regulation Division concerned.

Section 5. When the Product is Found Not Counterfeit. When the result of the examination reveals that the sample collected is genuine, the PSD or LSD shall forward the report of examination or evaluation to the FDRO through his/her division chief.

If the sealed and segregated products are within the Metro Manila area, the Regulation Division concerned, shall within sixteen (16) working hours from receipt of such report, notify the outlet or the communication available. However, only a FDRO can unseal the suspected product before it can be released for sale or distribution to legitimate commerce.

When the segregated and sealed product are located outside the Metro Manila area, the Regulation Division concerned shall send a notice to release the product to the Food and Drug Section having territorial jurisdiction over the same through the Regional Director within sixteen (16) working hours from receipt of the notice. The FDRO assigned in the said province shall, within sixteen (16) hours from receipt of the notice, unseal the suspected drugs for distribution to legitimate commerce.

Section 6. Possession of Counterfeit Drugs by Owners of Trademark, Trade Names or Other Identifying Marks: When to Report. Owners of trademarks, trade names or other identifying marks, shall report in writing and turn over the said counterfeit drugs to the BFAD within ten (10) days from the time of purchase or acquisition of such drugs as indicated in the sales invoices or official receipts or other similar documents. The sales invoice, official receipts or other similar documents shall be attached to the said report on counterfeit drugs. Failure to comply with this section will give rise to the presumption of violation as provided under Section 4 (a) of RA 8203.

RULE IV. PROCEDURE IN THE FILING OF ADMINISTRATIVE COMPLAINT

Section 1. Where to File the Complaint. Any person may file a complaint whether in an affidavit or letter with the BFAD LICD or in any BFAD Accredited Complaint Desk as provided for in Section 8, Rule II of this order.

Section 2. Complaint Filed by a Registered Brand Name. A drug establishment or a registered brand owner may file an administrative action against any person or establishment for any acts in violations of RA 8203 in the form of an affidavit of complaint.

Section 3. Contents of the Complaint Affidavit. The affidavit of complaint of the registered brand owner shall state:

name of the product, the lot number and expiry date of the product he shall allege as counterfeit;

name and address of the person and/or drug establishment or company he shall name as party-respondent;

specific acts that shall allege as having been committed by the party-respondent;

remedy or relief or action he shall intend BFAD to take.

The affidavit of complaint shall be accompanied by samples of counterfeit drug products duly marked for identification purposes.

Section 4. Complaint Filed By A Consumer, A Physician Prescriber and Other Interested Party. A consumer, physician-prescriber or other interested party other than the registered brand owner may file a letter of complaint or information about a suspected counterfeit drug product. His letter shall state:

name of suspected product;

the source or the name and address of the person from whom he/she acquired the said suspected drug product;

the mode of his acquisition;

the reason or fact giving rise to the suspicion that the drug product is counterfeit.

Section 5. When The Consumer, Physician Prescriber or Interested Party May File An Affidavit Of Complaint And Not A Letter Of Complaint. When the consumer, physician-prescriber or other interested party is in possession of evidence to prove that the product is counterfeit and an act in violation of RA 8203 has been committed, he/she shall file an affidavit of complaint stating:

the name and address of the person who has committed the act in violation of RA 8203

the specific acts committed.

He/She shall submit and submit and offer the evidence in his/her possession specifically including the sample of the counterfeit drug product or the container of such product he shall allege as counterfeit. Such an affidavit of complaint shall be processed in accordance with Section 3 of Rule IV hereof.

RULE V. ADMINISTRATIVE PROCEEDINGS

Section 1. When initiated by the BFAD FDRO?s. When the administrative action is initiated by FDRO, the FDRO shall submit a report of violation to the LICD.

Upon receipt of the report of violation and when such report is found in form and substance, the LICD shall immediately prepare the formal charge in the form of a memorandum of evidence. The memorandum of evidence shall contain a statement giving the party-respondent fifteen (15) working days within which to file his position paper and submit evidence contrary to that which was found, or justifying the acts in violation of RA 8203, failing in which, the case will be considered submitted for resolution based upon the evidence.

If the party-respondent is a drug establishment, outlet or business establishment, the memorandum of evidence shall be accompanied by a preventive closure order for thirty (30) days from the receipt of the order.

If the position paper filed by the respondent shall raise no factual issues that necessitates a trial, the case will be considered submitted for resolution.

If the position paper will raise factual issues necessitating a trial, or the respondent moves for a hearing to confront the witnesses upon which the memorandum of evidence was instituted, a hearing will be conducted.

In the hearing, upon motion of the respondent, the witnesses upon which the memorandum of evidence was instituted, shall file their reports. If any, the party-respondent shall be given the opportunity to confront or cross-examine the said witnesses.

After such affirmation and cross-examination, the party-respondent shall be given another ten (10) working days to supplement his position paper to manifest his intention to present evidence in support of his position paper, if he shall so intend.

In case the party-respondent manifests his intention to present evidence in support of his position paper, the continuation of the hearing shall be conducted. Otherwise, the case shall be considered submitted for resolution based on evidence on record.

The administrative proceedings shall be completed and terminated within the thirty (30) day period, otherwise, if such proceedings can not be completed within the thirty (30) days period from notice, an order lifting the preventive closure shall be issued without prejudice to the resolution of the administrative case.

Section 2. Procedure When A Complaint Is Based On A Letter Of Complaint Or Information.

Upon receipt of the letter of complaint or information about a suspected counterfeit drug, and upon a preliminary finding that there is sufficient basis to conduct an investigation, the letter of complaint or information will be assigned to an FDRO for verification.

If the information is verified, in fact the drug product is counterfeit and that a person, a drug outlet, or business establishment or drug establishment has committed acts in violation of RA 8203, a memorandum of evidence shall be issued and the administrative proceedings provided for in Section 1 hereof shall be instituted.

Section 3. Procedure When A Complaint Is Initiated By A Drug Establishment Or Registered Brand Owner.

Upon receipt of the complaint and a finding that the complaint is proper in form and substance, the party-respondent shall be summoned to answer within fifteen (15) days from receipt thereof.

The party-respondent shall file an answer and not a motion to dismiss except when the subject matter of the complaint is not within the administrative jurisdiction of the BFAD.

The hearing of the case shall be summary in nature and that direct testimonies of the witnesses shall be reduced to an affidavit which shall be submitted within three (3) days before the date of the hearing.

Section 4. Decision. Administrative cases under RA 8203 and these implementing rules and regulations shall be decided by the Director of BFAD within thirty (30) days from the date it shall be deemed submitted for decision.

Section 5. Finality of Decision/Resolution. Decisions and resolutions shall be final and executory after the lapse of fifteen (15) days from receipt of parties or from notice.

RULE VI. APPEAL

Section 1. Motion for Reconsideration; When and When Not Allowed. No motion for reconsideration from an interlocutory order shall be allowed. Only one motion for reconsideration from the final resolution or decision shall be allowed and only upon the grounds that:

the resolution is not supported by substantial evidence, and;

the conduct of the administrative investigation is attended with irregularity.

Section 2. Appeal: When. The aggrieved party may appeal the decision of the BFAD Director within fifteen (15) days from receipt thereof to the Secretary of Health.

Section 3. Grounds For Appeal. No appeal shall be given due course on the following grounds:

Abuse of discretion;

Decision is not supported by substantial evidence; or

Irregularity in the conduct of investigation.

Section 4. How Appeals Are Made. A party who intends to appeal the decision of the BFAD Director shall file a notice of appeal with the BFAD. The BFAD shall forward the records of the case to the Office of the Secretary within fifteen (15) days from receipt of the notice of appeal.

Section 5. Execution Pending Appeal. The appeal when filed by a respondent shall not stay the execution of the decision, unless a bond in the amount of one hundred thousand pesos (PhP 100,000.00) which is the minimum administrative fine imposable, is posted.

RULE VII. ADMINISTRATIVE SANCTIONS

Section 1. Minimum Penalty. An administrative fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than five hundred thousand pesos (PhP 500,000.00) shall be the minimum administrative penalty.

Section 2. Medium Penalty. An administrative fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than three hundred thousand pesos (PhP 300,000.00) and permanent closure of the establishment shall be the medium administrative penalty.

Section 3. Maximum Penalty. An administrative fine of not less than three hundred thousand pesos (PhP 300,000.00) but not more than five hundred thousand pesos (PhP 500,000.00) and the permanent closure of the establishment as well as the revocation of the licenses to do business shall be the maximum administrative penalty.

Section 4. Accessory Penalties.

Upon order of the court, all administrative shall be accompanied by forfeiture, confiscation and destruction of products found to be counterfeit and the equipment, instrument and other articles used in violation of RA 8203.

Permanent disqualification of the person concerned, whether natural or juridical, from owning or operating an establishment engaged in any business activity under the supervision of the BFAD shall be imposed together with the maximum administrative penalty.

Section 5. Proceedings Against The Registration Of A Pharmacist. If the offense shall be committed with the actual or constructive knowledge of the registered pharmacist, the administrative sanction that shall be imposed shall be accompanied by the filing of certificate of violation for the appropriate proceedings against said pharmacist with the Professional Regulations Commission to cancel his/her professional license.

Section 6. When To File Criminal Charges. Criminal charges shall be filed against the party liable when the evidence found by BFAD is considered sufficient to establish a probable cause and the drug products involved are life saving or if the drug products are not life saving, the volume or number of the drug products subject of the case will manifest the criminal intent of the party liable to introduce into commerce counterfeit drug products. This, however, shall not preclude any interested party from initiating a criminal action against the party liable independent of BFAD.

Section 7. When the Minimum Penalty Shall Be Applied. The minimum administrative penalty shall be imposed when the counterfeit drug products subject of the case are not life saving and the volume of the said products is not worth more than one hundred thousand pesos (PhP 100,000.00); or the number of drug product subject of the case is not more than three brands or generic products.

Section 8. When the Medium Penalty Shall Be Applied. The medium administrative penalty shall be imposed when the counterfeit drug products subject of the case are not life saving and the volume of the said products is worth more than one hundred thousand pesos (PhP 100,000.00) but not more than one million pesos (PhP 1,000,000.00); or the number of drug product subject of the case is more than three brands or generic products.

Section 9. When the Maximum Penalty Shall Be Applied. The maximum administrative penalty shall be imposed when the counterfeit drug products subject of the case are life saving regardless of the volume; or the volume of the counterfeit drug products is worth more than one million pesos (PhP 1,000,000.00.

RULE VIII. FINAL PROVISIONS

Section 1. Separability. If, for any reason, any part or provision of these rules and regulations shall be held to be unconstitutional or invalid, other parts or provisions hereof which are not affected thereby shall continue to be in full force and effect.

Section 2. Prospectivity. The administrative sanctions herein imposed shall not apply to acts committed prior to October 26, 1996 or the effectivity of the law RA 8203.

Section 3. Amendments. These rules and regulations maybe amended, modified or supplemented when effective implementation and enforcement of RA 8203 would require.

Section 4. Effectivity. This order shall take effect thirty (30) days after its publication in two (2) newspapers of general circulation.

PRIMER ON REPUBLIC ACT 8203, AN ACT PROHIBITING COUNTERFEIT DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND APPROPRIATING FUNDS THEREFOR

What is the short title of RA 8203?

The ?Special Law on Counterfeit Drugs?.

When did RA 8203 become effective?

After October 26, 1996, which is the fifteenth day following its publication in the newspapers ?Manila Standard on October 10, 1996 and ?Today? on October 11, 1996.

What agency of the government shall administer and supervise the implementation of RA 8203??

The Bureau of Food and Drugs of the Department of Health (DOH).

What are the declared state policies under RA 8203?

The State shall protect and promote the right to health of the people and still health consciousness among them as provided in Section 15, Article 11 of the Constitution, and to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs.

In line with the declared State policies, how shall the words and phrases of the Implementing Rules

and Regulations (IRR of RA 8203) be interpreted?

The words and phrases of the IRR of RA 8203 shall be interpreted to give meaning to the provisions of the Act in order to safeguard the health of the people and to protect them from counterfeit drugs.

For purposes of RA 8203, how are counterfeit drugs or medicines defined?

Counterfeit drugs/medicines refer to medicinal products with the correct ingredients but not in amounts as provided hereunder, wrong ingredients, with the insufficient quantity of active ingredients, which results to the reduction of the drug?s safety, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to?

The drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without the authorization or trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person.

A drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used.

An unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records.

And a drug which contain no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration.

When may an unregistered imported drug be considered counterfeit?

When such unregistered imported drug has a registered counterpart branded or generic drug in the Philippines Bureau of Food and Drugs.

What are prohibited acts under RA 8203?

The following acts are declared unlawful and therefore prohibited:

The manufacture, sale or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation of counterfeit drugs.

Possession of counterfeit drugs.

Forging, counterfeiting, simulating or falsely representing or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized by RA 3720 as amended, and /or regulations promulgated under RA 8203.

Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label or any part thereof, lawfully belonging to another person, for the purpose of using such label or a part hereof.

Making, selling or concealing any punch, dye, plate or any other equipment or instrument designedto print imprint or reproduce the trademark, trade name or other identifying mark of another registered product or any likeness thereof, upon any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade name.

What is meant by the prohibited act of brokering counterfeit drugs?

Brokering counterfeit drug means any act of facilitating the disposal or sale of counterfeit drugs including acts of agency.

When the act is punishable by RA 8203 and also by other existing laws, under what law should the

accused or respondent be prosecuted?

If warranted by the evidence, the offender shall be prosecuted under the law prescribing the highest penalty.

What constitute a prima facie evidence of manufacture, sale or offering for sale, donation,

trafficking, brokering, importation or possession of counterfeit drugs?

The presence or availability of counterfeit drugs in the premises of any entity engaged in the sale, manufacture, distribution of drugs-and/or-pharmaceutical products or in a private residence or in public or private vehicle or in the premises not covered by a valid license to operate from the BFAD.

This presumption shall not apply however to legitimate owners of trademarks, trade names or other identifying marks, or the legitimate or authorized representatives or agents of such owners who have in their possession counterfeit drugs which bear the trademarks, trade names or marks if they can show the sales invoices or official receipts evidencing their purchase from a drugstore, manufacturer or distributor suspected by them of dealing in counterfeit drugs involving the trademarks, trade names and other similar identifying marks registered in their names provided that they shall report the acquisition of those drugs and turn over the same to the BFAD within ten (10) days from the time of purchase or acquisition of such drugs as indicated in the sales invoices or official receipts or other similar documents.

Who shall be the parties liable for violation of RA 8203?

The manufacturer, exporter or importer of the counterfeit drugs and their agents: Provided, that the agents shall be liable only upon proof of actual or constructive knowledge that the drugs are counterfeit.

The seller, distributor, trafficker, broker or donor and their agents, upon proof of actual or constructive knowledge that the drugs sold, distributed, offered or donated are counterfeit.

The possessor of counterfeit drugs.

The manager, operator or laboratory facilities used in the manufacture of counterfeit drugs.

The owner, proprietor, administrator, or manager of the drugstore, hospital, pharmacy or dispensary, laboratory or other outlets or premises where the counterfeit drug is found who induces, causes or allows the commission of any prohibited act;

The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells or dispenses such drug to a third party and who shall have actual or constructive knowledge that said drug is counterfeit.

Should the offense be committed by a juridical person, the president, general manager, the managing partner, chief operating officer or the person who directly induces, causes or knowingly allows the commission of the offense shall be penalized.

What is constructive knowledge?

For purposes of RA 8203, constructive knowledge shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he or she has sold, is selling or in possession of is counterfeit, such as, but not limited to the knowledge, that the drug was not covered by any sales invoice or evidence of delivery or purchase from a BFAD licensed drug establishment.

Who monitors the presence of counterfeit drugs?

The designated officers of the BFAD under the Department of Health or the Food and Drug Regulation Officers (FDRO?s).

How are counterfeit drugs monitored by FDRO?s of the BFAD?

By inspection upon the authority conferred upon them under Section 27 of RA 3720 as amended.

What acts are performed in the conduct of monitoring counterfeit drugs?

In the course of the FDRO?s inspection of a factory, warehouse, establishment or vehicle, the FDRO shall further determine during such inspection, whether the drugs that they shall find are counterfeit or not. If they shall suspect that certain drugs are counterfeit, they shall conduct an inventory, segregate and seal the suspected stocks, collect samples and submit them for examination to determine their genuineness and authenticity. They shall require the owner or the representative of the establishment or outlet they are inspecting to produce the invoice or delivery receipts or documents covering the suspected counterfeit drugs.

Can the suspecting FDRO recognize or acknowledge any document covering the suspected

counterfeit or counterfeit drugs?

No. They can only honor invoices or documents that they have been issued by a BFAD licensed manufacturer, trader, distributor, wholesaler or importer with the lot number and expiry date of the drug products indicated therein.

May the FDRO take into his/her custody counterfeit products he/she shall find during inspection?

Yes. When he/she is certain that the drug is counterfeit and the counterfeit drugs are found during his/her routine or regular inspection of any factory, warehouse, or establishment in which drugs are manufactured, processed, packed or held, for introduction into domestic commerce.

What action will be taken by the BFAD if the suspected counterfeit drugs are found in the private

residence or in the premises not covered by a valid license to operate by BFAD?

The BFAD authorized officer or deputized officer shall secure a search warrant for the purpose of seizing and taking into custody such suspected counterfeit drugs.

What legal action will BFAD undertake upon finding that the suspected drug product is counterfeit?

The BFAD shall issue an order directing the preventive closure of the business establishment for a period not exceeding thirty (30) days and initiate administrative proceedings where the respondent shall be given the opportunity to be heard and present evidence in his behalf.

How does BFAD initiate the administrative proceeding?

By issuing a notice in the form of a memorandum of evidence (ME) informing the respondent of the charges against him and providing him with a copy of the evidence therefore.

What is the procedure adopted for administrative investigations under the IRR of RA 8203 upon

BFAD?s own motion or motu propio?

The BFAD by its Legal, Information and Compliance Division (LICD) issues an ME that they will include an Order of Preventive Closure for thirty (30) days to inform the respondent of the nature of the charges and the evidence upon which such charges are being made.

The respondent is given the opportunity to submit evidence contrary to what may have been found and/or a position paper within fifteen (15) days from his receipt of the ME. A trial, summary in nature, will be held in cases where the respondent shall move for a hearing, or when factual issues raised in the position paper.

After hearing the evidence upon which the ME has been issued, where such is applicable, the party respondent shall be given another ten (10) days to supplement his position paper or to manifest his intention to present evidence in support of his position paper. If he shall not so manifest, the case will be considered submitted for resolution based on the evidence on record.

When may preventive closure of an establishment be lifted?

If after the lapse of thirty (30) days from its effectivity, the administrative proceedings could not be completed. The preventive closure shall be lifted without prejudice to the resolution of the administrative case.

Who may file an administrative complaint under RA 8203?

Any interested party including the legitimate manufacturer or registered owner of the genuine drug product, consumer and physician-prescriber.

How may a complaint be filed?

By executing an affidavit of complaint, if the complaint is in possession of evidence to prove that the respondent has committed any of the unlawful act defined under RA 8203; and submitting therewith samples of the counterfeit drug.

The Affidavit of complaint shall state the following:

the name of the product including the lot number and expiry date;

the name and address of the person and/or the drug establishment or company who has committed the unlawful act;

iii. a description of the unlawful act committed, and

the remedy or relief of action he shall intend BFAD to take.

By a letter of complaint or information about the presence of a counterfeit drug: The letter shall state

the name of the suspected product;

the source or the name and address of the person from whom he/she acquired the said suspected drug product;

iii. the mode of his acquisition, and

the reason or fact giving rise to the suspicion that the product is counterfeit.

What administrative procedure will be conducted in cases where affidavit of complaint for violation

of RA 8203 is filed with BFAD?

When the complaint is found proper in form and substance, the party-respondent will be summoned to answer within fifteen (15) days from receipt.

The respondent shall file and answer and not a motion to dismiss except when the subject matter of the complaint is not within the administrative jurisdiction of the BFAD.

After the answer, a hearing shall be conducted which will be summary in nature. The direct testimony/testimonies of the witness shall be reduced to an affidavit which shall be submitted within three (3) days before the date of the hearing.

What administrative procedures will be undertaken in cases where a letter of complaint or

information will be filed?

The BFAD will follow the procedure adopted for motu proprio administrative investigation, when the information submitted shall have been verified by its FDRO.

What are the administrative sanctions or penalties imposable under RA 8203?

Minimum Penalty.The minimum administrative penalty is a fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than five hundred thousand pesos (PhP 500,000.00).

Medium Penalty.The medium administrative penalty is a fine of not less than one hundred thousand pesos (PhP 100,000.00) but not more than three hundred thousand pesos (PhP 300,000.00) and permanent closure of the establishment as well as the revocation of the license to do business.

Maximum Penalty. The maximum administrative penalty is a fine of not less than three hundred thousand pesos (PhP 300,000.00) but not more than five hundred thousand pesos (PhP 500,000.00) and the permanent closure of the establishment as well as the revocation of the licenses to do business.

What are the accessory penalties?

All administrative penalties shall be accompanied by forfeiture, confiscation and destruction of products found to be counterfeit and the equipment, instrument and other articles used in violation of RA 8203.

Permanent disqualification of the person concerned, whether natural or juridical, from owning or operating an establishment engaged in any business activity under the supervision of the BFAD shall be imposed together with the maximum administrative penalty.

When may BFAD recommend the cancellation of the registration of the pharmacist-respondent with

the Professional Regulations Commission?

When the pharmacist-respondent has actual or constructive knowledge of the offense committed.

When Will The Minimum Penalty Be Imposed?

The minimum administrative penalty shall be imposed when the counterfeit drug products subject of the case

are not life saving and the volume of the said products is not worth more than one hundred thousand pesos

(PhP 100,000.00); or the number of drug product subject of the case is not more than three brands or generic

products.

When Will The Medium Penalty Be Imposed?

The medium administrative penalty shall be imposed when the counterfeit drug products subject of the case

are not life saving and the volume of the said products is worth more than one hundred thousand pesos (PhP

100,000.00) but not more than one million pesos (PhP 1,000,000.00); or the number of drug product subject of

the case is more than three brands or generic products.

When Will The Maximum Penalty Be Imposed?

The maximum administrative penalty shall be imposed when the counterfeit drug products subject of the case

are life saving regardless of the volume; or the volume of the counterfeit drug products is worth more than one

million pesos (PhP 1,000,000.00).

What is meant by life-saving drug?

Life-saving drug refers to the drug products indicated for life-threatening conditions.

What are the criminal penalties imposable for violation of RA 8203?

Imprisonment of not less than six (6) months and one (1) day, but not more than six (6) years for mere possession of counterfeit drugs.

Imprisonment of six (6) years and one (1) day but not more than ten (10) years or a fine of not less than one hundred thousand (PhP 100,000.00) but not more than five hundred thousand (PhP 500,000.00) or both such imprisonment and fine at the discretion of the court for all prohibited acts other than mere possession.

Imprisonment not less than six (6) months and one (1) day but not more than two (2) years and four (4) months if the counterfeit drug is intended for animals.

Imprisonment of not less than six (6) months and one (1) day but not more than ten (10) years for any manufacturer, seller, or distributor who shall conceal, substitute, dispose or destroy any drug as may have been segregated and sealed by the bureau or who shall break, alter or tamper any mark or seal used by the BFAD-FDRO who identify a segregated counterfeit drugs.

Imprisonment from twelve (12) years to fifteen (15) years and a fine ranging from one hundred thousand pesos (PhP 100,000.00) to five hundred thousand pesos (PhP 500,000.00) for any person who shall violate RA 8203, if, as result of the use of the drug found to be counterfeit, the illness sought to be cured is aggravated or physical injury or suffering results there from.

Life imprisonment and a fine of five hundred thousand pesos (PhP 500,000.00) to five million pesos (PhP 5,000,000.00) shall be imposed to any person who shall violate RA 8203 when the counterfeit drugs subject of the case will be the proximate cause of the death of the victim.

"An Act Strengthening The Meat Inspection System In The Country,
Ordaining For This Purpose A "Meat Inspection Code Of The Philippines"
And For Other Purposes

Senate Bill No. 2691
House Bill No. 6587

Republic of the Philippines

Congress of the Philippines

Metro Manila

TWELFTH CONGRESS

Third Regular Season

Begun and held in Metro Manila, on Monday, the twenty-eight day of July, two thousand three

REPUBLIC ACT NO. 9296

?AN ACT STRENGTHENING THE MEAT INSPECTION SYSTEM IN THE COUNTRY, ORDAINING FOR THIS PURPOSE A ?MEAT INSPECTION CODE OF THE PHILIPPINES? AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

SECTION 1. Short Title. ? This Act shall be known as ?The Meat Inspection Code of the Philippines.?

CHAPTER I

DECLARATION OF POLICY AND DEFINITIONS

SECTION 2. Declaration of Policy. ? it is hereby the policy of the State:

a) to promulgate specific policies and procedures governing the flow of food animals, meat and meat products through the various stages of marketing and the proper preservation and inspection of such products;

b) to ensure food security and provide safety and quality standards for consumer products related to agriculture to assure the protection of the public against unreasonable risks of injury and hazards to health;

c) to support local government units in their endeavor to be self - reliant and to continue exercising the powers and discharging the duties and functions currently vested upon them;

d) to strengthen and harmonize various issuances on meat establishment operations and meat inspection and at the same time create a favorable climate of investment to encourage the meat and poultry industry to put up world class meat establishments;

e) to promote the application of risk analysis based on accepted scientific methodology on applied food safety standards so as to assure a safe and wholesome meat supply.

f) to support the development of the livestock and poultry industry and promote animal health by preventing the entry of disease ? carrying animals, and surveillance of zoonotic and reportable diseases in meat establishments; and

g) to strengthen existing rules and regulations governing meat importation to make them comprehensive, clear and transparent and ensure the safety and quality of imported meat and meat products through inspection and documentation.

SECTION 3. Principles and Objectives ? The State shall ensure the protection of human and animal health against direct and indirect hazards, and in particular the protection of:

a) Consumers against zoonotic diseases, meat?borne infection, intoxication and hazards associated with residue from treatment or exposure of the slaughter animal;

b) Meat handlers against occupational zoonoses;

c) Livestock against the spread of infections, intoxications and other diseases of socio-economic importance as detectable at meat inspection and as consistent with the relevant animal health regulations; and

d) Consumers and the meat processing industry against economic losses from meat of inferior quality or abnormal properties.

SECTION 4. Definition of Terms. ? As used in this Code, the following terms, words and phrases shall be construed to mean as follows:

1. Abattoir or slaughterhouse? premises that are approved and registered by the controlling authority in which food animals are slaughtered and dressed for human consumption;

2. Accredit - The power of the National Meat Inspection Service (NMIS)to give authority to (a) any meat establishment engaged in the slaughtering operation, preparation, processing, manufacturing, storing, or canning of meat and meat products for commerce, (b) any importer, exporter, broker, trader or meat handler (c) any meat vehicle or conveyance (d) any person firm, corporation as provider of government services such as independent or third party service providers, or independent or audit agencies;

3. Adulterated ? carcasses, or any part thereof, whether meat or meat product under one or more of the following categories;

a) if it bears or contains any poisonous or deleterious substance which may render it injurious to health of the public; but in case the substance is not an added substance, such meat and meat product shall not be considered adulterated under this clause if the quantity of such substance does not ordinarily render it injurious to health of the public;

b) if it bears or contains any added poisonous or deleterious substance other than one which is (i) a pesticide chemical in or on a raw agricultural commodity, (ii) a food additive, (iii) a color additive, for which tolerances have been established and it conforms to such tolerances;

c) if it consists in whole or in part of a filthy, putrid or decomposed substance, or if it is otherwise unfit for human consumption;

d) if it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth or whereby, it may have been rendered injurious to the health of the public;

e) if it is, in whole or in part, the product of a diseased animal or of an animal which has died other than slaughter;

f) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to public health;

g) if its has been intentionally subjected to radiation, unless the use of the radiation was in conformity with an existing regulation or exemption;

h) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is;

i) if it has not been prepared in accordance with current acceptable manufacturing practice as promulgated by the Secretary by way of regulations; or

j) if it has passed its expiry date.

4. Board? the Meat Inspection Board of the NMIS as created under Section 6 hereof;

5. Canning? the preservation of meat in hermetically sealed containers;

6. Capable of Use as Human Food - shall apply to any carcass or any part of a carcass, of any animal unless it is denatured or otherwise identified as required by regulations prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans;

7. Carcass? the body of any slaughtered animal after bleeding and dressing;

8. Commence? meat trade between a province within the Philippines and any place outside thereof;

9. Controlling Authority? the official authority charged by the government with the control of meat hygiene and meat inspection;

10. Deputation ? the authority of the NMIS to allow inspectors and meat control officers employed by the local government units to perform the duties of an inspector or meat control officer of the NMIS;

11. Disease or Defect? a pathological change or other abnormality;

12. Firm ? any partnership, association, or other unincorporated business organization;

13. Fit for Human Consumption? meat that has passed and appropriately branded by an inspector as safe and wholesome and in which no changes due to disease, decomposition or contamination have subsequently been found;

14. Fresh Meat? meat that has not yet been treated in any way other than by modified atmosphere packaging or vacuum packaging to ensure its preservation except that if it has been subjected only to refrigeration, it continues to be considered as fresh;

15. Food Animal? all domestic animals slaughtered for human consumption such as but not limited to cattle, carabaos, buffaloes, horses, sheep, goats, hogs, deer, rabbits, ostrich and poultry;

16. Inspected and Passed? a condition wherein the carcasses or parts of carcasses so marked have been inspected and found to be safe, wholesome and fit for human consumption;

17. Inspected and Condemned ? a condition wherein the carcasses or parts of carcasses so marked have been inspected and found to be unsafe, unwholesome and unfit for human consumption;

18. Inspection? an act by an official inspector to ensure compliance with rules and regulations including but not limited to humane handling of slaughter animals, ante and post mortem inspection, quality assurance program, hygiene and sanitation program, good manufacturing program, sanitation standard operating procedures, hazard analysis critical point program on any meat and meat product, meat establishment facilities, transport vehicles and conveyance;

19. Inspector? a professionally qualified and properly trained officer, duly appointed by the NMIS or the local government unit for meat inspection and control of hygiene under the supervision of a veterinary inspector;

20. Label? a display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article;

21. Meat? refers to the fresh, chilled or frozen edible carcass including offal derived from food animals;

22. Meat Broker ? any person, firm or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of food animals on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm or corporation;

23. Meat Establishment?premises such as slaughterhouse, poultry dressing plant, meat processing plant, cold storage, warehouse and other meat outlets that is approved and registered by the NMIS in which food animals or meat products are slaughtered, prepared, processed, handled, packed or stored;

24. Meat Inspection System? a system to ensure the safety and quality of meat and meat products for human food including but not limited to humane handling of slaughter animals, ante?mortem and post?mortem inspection, Quality Assurance Program, Hygiene and Sanitation Program, Good Manufacturing Practices, Sanitation Standard Operating Procedures, Hazard Analysis Critical Control Point Program, and Residue Control Program, of a country. It covers regulatory activities such as registration, licensing, accreditation, and enforcement of regulations and supported by laboratory examination;

25. Meat Product? any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any food animals, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat industry, and which are exempted from definition as a meat product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such Carcasses contained in such product are not adulterated and that such products are not represented as meat products;

26. Misbranded ? this term shall apply to any carcass, part thereof, meat or meat products where one or more of the following circumstances as defined under the R.A. No. 7394 (Consumer Act of the Philippines) is present:

a) if its labeling is false or misleading in any particular;

b) if it is offered for sale under the name of another meat or meat product;

c) if it is an imitation of another meat or meat product, unless its label bears, in type of uniform size and prominence, time word ?imitation? and immediately thereafter, name of the meat or meat product imitated;

d) if its container is so made, formed, or filled as to be misleading;

e) if in a package or other container unless it hears a label showing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this subparagraph (e), reasonable variations may be permitted, and exemptions as to small packages shall he established, by regulations prescribed by the Secretary;

f) if any word , statement, or other information required by or under authority of this chapter to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

g) if it purports to be or is represented as a meat or meat product for which a definition and standard of identity or composition has been prescribed by regulations of the Secretary under this title unless (1) it conforms with such definition and standard, and (2) its label bears the name of the meat or meat product specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such meat product;

h) if it purports to be or is represented as a meat or meat product for which a standard or standards of fill of container have been prescribed by regulations of the Secretary under this title and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner anti form as such regulations specify, a statement that it falls below such standards;

i) if it is not subject to the provisions of subparagraph (g), unless its label hears (a) the common or usual name of meat products, if any there be, and (b) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and coloring may, when authorized by the Secretary, be designated spices, flavorings, and colorings without naming each: Provided, That to the extent that compliance with the requirements of clause (b) of this subparagraph (i) is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary;

j) if it purports to be or is represented for special dietary use, unless its label hears such information concerning its vitamin, mineral, and other dietary properties as determined by the Secretary, and by regulations prescribed as necessary in order to fully inform purchasers as to its value for such uses;

k) if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That to the extent that compliance with the requirements of this subparagraph (k) is impracticable, exemptions shall he established by the regulations promulgated by the Secretary; or

l) if it fails to bear, directly on its container, as the Secretary may by regulations prescribe, the inspection mark or legend and, unrestricted by any of the foregoing, such other information as the Secretary may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.

27. Official Certificate- any certificate prescribed by the Secretary for issuance by an inspector or other person performing official functions under this chapter;

28. Official Device ? any device prescribed by the Secretary for use in applying any official mark;

29. Port of Inspection ? an establishment authorized or designated by the NMIS within a certain kilometer radius from the port of entry, wherein inspection and collection of samples is being conducted prior to its release for domestic distribution;

30. Prepared ? slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed;

31. Processed ? includes all methods of manufacture and preservation but does not include prepackaged fresh, chilled or frozen meat;

32. Residue ? any Foreign substance including metabolites, therapeutic or prophylactic agents which are objectionable or hazardous to human health remaining in the meat or meat products as a result of treatment or accidental exposure;

33. Risk Analysis ? a process consisting of three (3) components that includes risk assessment, risk management and risk communication, all of which are essential to the decision making process that determines acceptable levels or risk, and the implementation of those decisions;

34. Safe and Wholesome ? refers to meat and meat products that has been passed as fit for human consumption using the criteria that it (a) will not cause food borne infection or intoxication when properly handled and prepared with respect to the intended use, (b) does not contain residue in excess of set limits, (c) is free of obvious contamination, (d) is free of defects that are generally recognized as objectionable to consumers, (e) has been produced under adequate hygiene control, and (f) has not been treated with illegal substances as specified in this Act and in other related national legislation;

35. Secretary ? refers to the Secretary of the Department of Agriculture and Chairman of the National Meat Inspection Service;

36. Veterinary Inspector or Meat Control Officer ? an inspector who is professionally qualified as a veterinarian duly appointed by the NMIS or the local government unit responsible for the supervision and control of meat hygiene including meat inspection.

CHAPTER II

INSTITUTION

SECTION 5. The National Meat Inspection Service (NMIS) ? The National Meat Inspection Commission renamed as the National Meat Inspection Service (NM1S) shall serve as the sole national controlling authority on all matters pertaining to meat and meat product inspection and meat hygiene. It shall be a specialized regulatory service attached to the Department of Agriculture.

SECTION 6. The Meat Inspection Board ? There is hereby created a Meat Inspection Board under the NMIS who shall assist in the formulation of policies and guidelines and advise the Chairperson on all matters pertaining to meat inspection and meat hygiene. The Board shall be composed of the following or their duly designated representatives:

1. The Secretary of the Department of Agriculture, as Chairperson;

2. The Executive Director of the National Meat Inspection Service;

3. The Director of the Bureau of Animal Industry;

4. The Executive Director of the Bureau of Food and Drugs;

5. The Director of the Bureau of Local Government Development;

6. Representative from a consumer organization duly recommended by the National Consumer Affairs Council, and

7. The Director of the Bureau of Agriculture and Fisheries Product Standards.

SECTION 7. Composition of the NMIS. - The NMIS shall be headed by an Executive Director, The administrative, technical and support services of the NMIS shall be strengthened as may be appropriate and necessary to carry out effectively the provisions of this Act.

SECTION 8. Powers and Functions of NMIS ? The NM IS shall be vested with the following powers and functions:

1) Formulate and issue and implement jointly with the appropriate local government units national policies, guidelines, rules and regulations and programs including but not limited to:

a) establishing safety and quality standards for meat and meat products in consultation with the product standard setting agencies;

b) adopting measures to ensure pure, wholesome and safe supply of meat and meat products of the country;

c) accrediting establishment, facilities, conveyance and service providers for Hazard Analysis Critical Control Point Program (HACCP) audit;

d) licensing of meat inspectors and registration of meat handlers;

e) licensing, registration and certification of meat handlers and meat brokers;

f) licensing, registration and certification of meat and meat products;

g) implementing standards prescribed by the Bureau of Agriculture and Fisheries Product Standards (BAFPS) on labeling, advertising and promotion of meat and meat products.

2) Supervise and control meat inspection in all meat establishments engaged in domestic and international meat trade;

3) Evaluate, classify and accredit local and foreign meat establishments as to compliance to hygiene and sanitation standards;

4) Foster effective exchange of information and coordination of programs, projects and activities among various agencies;

5) Undertake training of all persons employed in meat inspection work;

6) Recommend measures to professionalize the meat inspection service to the Professional Regulation Commission;

7) Seek the assistance of any department, bureau, office, agency or instrumentality of the government or other private entities and organizations for cooperation in the performance of its functions.

SECTION 9. Regional Technical Operation Centers. ? Upon the effectivity of this Act, the existing regional offices of the NMIS shall be scaled down and transformed into meat laboratories and technical operation centers to be manned by a minimum number of medical and technical personnel whose qualifications shall be determined by the Secretary of Agriculture to effectively carry out the provisions of this Act. Within two (2) years from the effectivity of this Act the functions of the aforementioned regional/technical operations centers of the NMIS shall be transferred or devolved to the provincial government where said offices are located: Provided, That the Provincial Meat Inspection Service are certified to be compliant with national standards. However, certification for international trade shall remain with the NMIS.

CHAPTER III

RESPONSIBILITIES OF THE LOCAL GOVERNMENT UNITS

SECTION 10. Regulation by Local Government Units ? The local government units, pursuant to the provisions of Republic Act 7160 otherwise known as the Local Government Code and Executive Order No. 137, shall regulate the construction, management and operation of slaughterhouses, meat inspection, meat transport and post?abattoir control, monitor and evaluate and collect fees and charges in accordance with the national policies, procedures, guidelines, rules and regulations and quality and safety standards as promulgated by the Secretary.

SECTION 11. Implementation by the Local Government Units. ? The local government units shall have full and complete authority over the activities mentioned in the immediately preceeding section as the authority to evaluate and implement duly prescribed national meat standards within their respective territorial jurisdiction.

In order to improve slaughter facilities and strengthen local meat inspection services, the share of the local government units with regard to ante? and post?mortem fees collection to the provision of the Local Government Code and Executive Order No. 137 shall be retained.

For the same purposes, an amount equivalent to twenty percent (20%) of amounts collected from fees, fines and other charges by the NMIS mentioned in Sections 46 and 56 hereof in the enforcement and implementation of national meat standards shall, except for a reasonable fee for services rendered, automatically inure to local government units which shall retain said amount at source.

SECTION 12. Incentive for Local Government Units. ? The local government units shall endeavor to improve existing meat facilities to comply with national standards. The national government shall allocate funds as incentive equivalent to the funds available from local government units for this purpose.

CHAPTER IV

SCOPE OF MEAT INSPECTION

SECTION 13. Scope of Application. - This Code shall apply to all meat establishments where food animals are slaughtered, prepared, processed, handled, packed or stored or sold. All slaughterhouses and poultry dressing plants shall ensure adequate protection and welfare of food animals while awaiting slaughter in order to avoid mishandling or the infliction of unnecessary pain or distress during the slaughtering process.

SECTION 14. Authorized Officers to Conduct Meat Inspection. ? Only meat control officers, deputized meat control officers, meat inspectors and deputized meat inspectors duly appointed and designated by the NMIS or local government units are authorized to conduct meat inspection work. All persons employed in meat inspection work shall undergo training conducted by the NMIS.

SECTION 15. Power to Enforce Hygienic Requirements. ? The NMIS shall have the responsibility to ensure, and to enforce, that meat establishments are operated in accordance with hygienic requirements.

SECTION 16. Humane Slaughter, Hygienic and Inspection Requirements. ? The management or operator of the meat establishments shall follow the instructions of the NMIS as related to humane slaughter of animals, hygienic and inspection requirements, and shall provide such information and assistance, as may be reasonably requested by the NMIS or the local government unit.

CHAPTER V

A. ANTE-MORTEM INSPECTION

SECTION 17. Requirement of An Ante-Mortem Inspection. ? An ante?mortem inspection shall be made of food animals by authorized inspectors before it shall be allowed for slaughter in any city, municipal or licensed private abattoirs in which the meat or meat products thereof are to be sold.

SECTION 18. Outright Condemnation. ? Any animal manifesting during ante?mortem inspection any disease or condition that shall warrant outright condemnation shall be marked ??CONDEMNED??, isolated immediately and disposed of under the supervision of an inspector.

SECTION 19. Humane Handling and Slaughtering. ? For the purpose of preventing the inhumane slaughtering of food animals under Republic Act No. 8485, otherwise known as the Animal Welfare Act, inspectors shall conduct an examination and inspection of the method by which food animals are slaughtered and handled in meat establishments inspected under this Act.

SECTION 20. Refusal to Allow Inspection ? The Secretary may refuse to allow inspection to a new slaughtering meat establishment or may cause inspection to be temporarily suspended in any establishment if the Secretary finds that food animals have been slaughtered or handled by any method not considered humane under the Animal Welfare Act, until the establishment furnishes satisfactory assurance that all slaughtering and handling shall be in accordance with such a method.

B. POST-MORTEM INSPECTION

SECTION 21 . Post-Mortem Inspection. ? The inspectors shall conduct, a post?mortem examination and inspection of the carcasses and parts thereof of all food animals prepared at any establishment as articles of commerce which are capable of use as human food.

SECTION 22. Proper Marketing of Carcasses. ? The carcasses and parts thereof of all such animals found not to be adulterated shall be marked, stamped, tagged or labeled as ??Inspected and Passed? Said inspectors shall label, mark, stamp or tag as ??Inspected and Condemned? all carcasses and parts found to be adulterated. All carcasses and parts thereof marked ?Inspected and Condemned? shall be destroyed for food purposes by the said establishment in the presence of an inspector.

SECTION 23. Re-Inspection. - The inspectors shall re-inspect carcasses and parts thereof when necessary to determine whether the meat has become adulterated after the first inspection. If found to be adulterated on subsequent examination and inspection, the establishment shall destroy for food purposes, all carcasses and parts thereof in the presence of an inspector.

SECTION 24. Extent of Application ? The foregoing provisions shall apply to all carcasses or parts of carcasses of food animals or the meat and meat products thereof which may be brought into any meat processing, meat canning, packing or similar establishment and such examination and inspection shall be done before the said carcasses or parts thereof shall he allowed to he treated, processed or prepared.

SECTION 25. Entry of Material into the Meat Establishments. ? The Secretary may limit the entry of carcasses, parts of carcasses, meat and meat products and other materials into any meat establishment at which inspection under this Act is maintained, under such conditions as may be prescribed to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this Act.

SECTION 26. Access to Meat Establishments. - The inspectors shall conduct an examination and inspection of all meat and meat products prepared for commerce in any slaughtering, meat canning, salting, packing, rendering, or similar establishment, and for that purpose, shall have access at all times, day or night, whether the establishment is in operation or not, to every part of said establishment.

SECTION 27. Marking of Inspected Products. ? The inspectors shall mark, stamp, tag, or label as ?Inspected and Passed? or ?Inspected and Condemned? all such products found to be unadulterated or adulterated as the case may be. Condemned meat Products shall be destroyed for food purposes: Provided, That subject to the rules and regulations under this Act, the provisions hereof in regard to preservatives shall not apply to meat products for export to any foreign country and which are prepared or packed according to the specifications or directions of the foreign purchaser, when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is to be exported.

SECTION 28. Veterinary Quarantine Clearance. ? No veterinary quarantine clearance issued by the National Veterinary Quarantine Service shall be given to any vessel having on board any meat and meat products for export to and sale in a foreign country from any port in the Philippines until the owner or shipper thereof shall obtain from the NMIS a certificate that the said food animal is free from dangerous and communicable diseases at the time of inspection, and that the meat therefrom is safe and wholesome. The Secretary may waive the requirements of? such certificate in favor of the country to which said meat and meat products arc to be exported.

SECTION 29. Official Certificates of the Condition of the Animals. ? The veterinary inspectors provided for herein shall he authorized to give official certificates of the condition of food animals, their carcasses and products as herein described, and one (1) copy of every certificate granted under the provisions of this Act shall be filed with the NMIS, another copy shall be given to the owner or shipper, and when the meat and meat products are sent abroad, a third copy shall be attached to veterinary quarantine clearance.

SECTION 30. Sale and Transport of Properly Labeled Carcasses. ? No person, firm or corporation shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any carcasses of food animals, or the meat or meat products thereof, unless they are plainly and conspicuously marked or labeled or otherwise identified as required by regulations prescribed by the Secretary to show the kind of animals from which they were derived.

SECTION 31. Absence of Ante?Mortem Inspection. ? The inspectors shall seize, confiscate, condemn or dispose of carcasses or parts thereof of food animals that is sold, transported, distributed, offered or received for distribution in commerce that has not passed through ante?mortem inspection. Carcasses or parts thereof are considered ?hot meat? and if found to be fit for human use during examination shall be disposed of as provided in the Implementing Rules and Regulations of this Act.

CHAPTER VI

INSPECTION OF IMPORTED MEAT AND MEAT FOOD PRODUCT

SECTION 32. Examination and Laboratory Analysis. ? The NMIS shall conduct examination and when necessary, laboratory analysis of imported meat and meat products after the products are approved for release by the National Veterinary Quarantine Service at the ports of entry.

SECTION 33. Confiscation of Meat and Meat Products. ? The inspectors shall seize, recall, confiscate, condemn or dispose by destruction or re-export at the expense of the importer, any imported carcass, meat or meat products of food animals that has been prepared, sold, transported or otherwise distributed or offered or received for distribution in commerce, and found to be filthy, contaminated, adulterated or misbranded during inspection and laboratory analysis.

SECTION 34. Accreditation of Foreign Meat Establishments. - Meat exporters to the Philippines shall secure accreditation of foreign meat establishment at source from the Department of Agriculture before being allowed to ship meat and meat products into the country. An audit or inspection shall be done of exporters of meat and meat products in terms of their compliance with Philippine and internationally recognized standards.

SECTION 35. Compliance Prior to Shipment. ? Meat exporters to the Philippines must comply with all other Philippine import requirements prior to the shipment of meat and meat products into the country.

SECTION 36. Import Requirements. ? Imported meat and meat products shall be refused entry if they do not meet Philippine import requirements. The refused entry items shall be re-exported to the country of origin or destroyed at the expense of the importer or owner in order to protect public health and the local animal population.

CHAPTER VII

LABELING REQUIREMENTS

SECTION 37. Labeling of Meat and Meat Products. ? Any meat or meat products prepared for commerce which has been inspected and marked ?Inspected and Passed? shall be placed or packed in any can, pot, tin, canvas, other receptacle or covering in any establishment where inspection under the provision of this Act is maintained. The person, firm or corporation preparing said product shall cause a label to be attached to the said can, pot, tin, canvas, or other receptacle or covering, under the supervision of an inspector, which label shall slate that the contents thereof have been ?Inspected and Passed? under the provision of this Act.

SECTION 38. Sealed Meat and Meat Products. ? No examination and inspection of meat and meat products deposited or enclosed in cans, tins, pots, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this Act is maintained shall be deemed to be complete until such meat or meat products have been sealed or enclosed in said can, tin, pot, canvas, or other receptacle or covering under the supervision of an inspector

SECTION 39. Distinct and Legible Labels. ?All carcasses, parts of carcasses, meat and meat products inspected at any establishment and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, directly thereon on their containers the information required under the provisions of this Act.

SECTION 40. Standards for Labeling. ? The Secretary, may prescribe: (1) the styles and sizes of type to be used, with respect to material required to he incorporated in labeling to avoid false or in misleading labeling, (2) definitions and standards of identity or composition for articles and standards of fill of container for such articles consistent with any such standards required by receiving countries.

SECTION 41. False or Misleading Marks and Labels. ? No article shall be sold or offered for sale by any person, firm or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size. Established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted.

SECTION 42. Withholding False or Misleading Marks and Labels. ? If the Secretary has reason to believe that any marking or labeling or the size or form of any container in use or proposed for use with respect to any article is false or misleading in any particular, he may direct that such use be withheld unless the marking, labeling or container is modified in such manner as he may prescribe so that it will not be false or misleading.

CHAPTER VIII

SANITATION

SECTION 43. Sanitation Inspection. - The Secretary shall require a sanitation inspection to be conducted by experts/ inspectors all meat establishment to gather information concerning the prevailing sanitary conditions and from such, shall prescribe the rules and regulations under which meat establishments shall be operated and maintained. Meat and meat products operated under sanitary conditions that render them adulterated, shall not be labeled or marked as ??Inspected and Passed??

CHAPTER IX

PRODUCT QUALITY AND SAFETY

SECTION 44. Standards and Guidelines. ? The Secretary, by way of regulation, shall adopt internationally recognized standards, recommendations, set of procedures or guidelines to further ensure the quality and safety of meat and meat products.

CHAPTER X

PRODUCT INFORMATION AND CONSUMER AWARENESS

SECTION 45. Information Campaign ? The NMIS shall have the responsibility to provide information and assistance to the consuming public on the proper handling and preparation, storing, processing, preservation of meat and meat products and may seek the assistance of the industry and the private sector in attaining its objectives.

CHAPTER XI

FEES AND CHARGES

SECTION 46. Fees. ? The Secretary, by way of regulation, and after public hearing, shall prescribe and charge such reasonable fees for services rendered. Amounts collected from fees, fines and other charges by the NMIS shall be deposited with the National Treasury and shall accrue to the General Fund.

SECTION 47. Meat Inspection Service Development Trust Fund. ? There shall be an independent and separate trust fund established under this Act, to be administered by the Meat Inspection Board. An amount not less than fifty percent (50%) for the first five (5) years, accrued from the fees, fines and charges shall be used for the purpose of the Meat Inspection Service Development Trust Fund. The fund shall be used for the continued upgrading of laboratory equipment and facilities to conform with international standards, training facilities, capability development of technical personnel, research and development, indemnification of condemned animals during ante?mortem inspection, accreditation of foreign meat plants and other forms of assistance and support to the livestock sector. The trust fund may also accept grants and donations from national and foreign entities and individuals interested in the meat inspection development.

CHAPTER XII

PROHIBITED ACTS

SECTION 48. Prohibited Acts. ? No person, firm or corporation shall:

a) slaughter any food animal or prepare meat or meat product in any meat establishment except in compliance with the requirements of this Act;

b) slaughter or handle in connection with slaughter, any food animal in a manner not considered humane;

c) sell, transport, offer or receive for sale or transportation in commerce carcasses or parts thereof, meat or meat product required to be inspected under this Act unless they have been so inspected and passed;

d) do any act while they are being transported in commerce or held for sale, which is intended to cause or has the effect of causing such articles to be adulterated or misbranded.

SECTION 49. Printing of Official Marks. ? No brand manufacturer, printer, or other person, firm, or corporation shall cast, print, lithograph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary.

SECTION 50. Forging Official Marks. ? No person, firm, or corporation shall ? (1) forge any official device, mark, or certificate; (2) use any official device, mark, or certificate, or simulation thereof, or alter, detach, deface, or destroy any official device, mark, or certificate; (3) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certificate; (4) knowingly possess, any official device or any counterfeit, simulated, forged, or improperly altered official certificate or any device or label or any carcass of any animal, or part or product thereof, bearing any counterfeit, simulated, forged, or improperly altered official mark; (5) knowingly make any false statement in any certificate; or (6) knowingly represent that any article has been inspected and passed under this Act when, in fact, it has not been so inspected and passed.

SECTION 51. Absence of Ante-Mortem Inspection. ? It shall be unlawful for any person, either for himself or in behalf of another person, firm or corporation or partnership to slaughter food animals which have not been submitted for ante?mortem inspection or to store, transport or sell carcasses, organs or parts thereof which have not been previously inspected and passed or have been found upon inspection to be unfit for human consumption.

SECTION 52. Interference in the Conduct of Inspection ? It shall be unlawful for any person, firm or corporation to resist, harass, intimidate, assault, impede or interfere with any inspector during the performance of his duties as prescribed under this Act.

SECTION 53. Unlawful Trading. ? It shall be unlawful for any person employed by the NMIS or person employed by the local government unit for the purpose of meat inspection work, to engage directly or indirectly in the business of buying, selling and trading or otherwise negotiating purchases or sales of meat and meat products for his own account or as an employee of another person, firm or corporation.

SECTION 54. Unlawful Shipment. - It shall he unlawful for any shipping line or airline to accept shipment of meat and meat products for export into our country without an accompanying veterinary quarantine clearance issued by the Philippine Department of Agriculture and International Veterinary Certificate issued by the national controlling authority of the exporting country.

CHAPTER XIII

ACCESS AND EXAMINATION

SECTION 55. Record Keeping. ? The following classes of persons, firms, and corporation shall keep such records and will fully and correctly disclose all pertinent transactions involved in their business; and all persons, firms, and corporations subject to such requirements shall, at all reasonable times, upon notice by a duly authorized representative of the Secretary, afford such representative access to their places of business and opportunity to examine the facilities, inventory, and records thereof ? (1) any person, firm, or corporation engaged in the business of slaughtering food animals, or preparing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any such animals, for use as human food (2) any person, firm, or corporation engaged in the business of buying or selling or transporting, or storing in, or importing, any carcasses, or parts or products of carcasses, of any such animals.

CHAPTER XIV

PENALTIES AND SANCTIONS

SECTION 56. Administrative Fines. ? The Secretary, by way of regulation, shall issue a schedule of administrative fines for violations of any provisions of this Act.

SECTION 57. Cease and Desist Order. - The Secretary is authorized to issue after proper notice and hearing which shall be summary in nature except in instances when the continued operation causes imminent danger to public health, a ??Cease and Desist Order?? to any person, firm, or corporation engaged, in the business of slaughtering food animals, or preparing, freezing, packaging, storing or labeling any carcasses or parts or products of carcasses for use as human food, found to be in violation of any of the provisions of this Act, should the continued operation of said entity, pose risk to public health and endanger the animal population.

SECTION 58. Confiscation. - Any carcasses, parts of carcasses or products of carcasses found to have been prepared, handled, packed, stored, transported or offered for sale as human food not in accordance with any provisions of this Act shall be confiscated and disposed of as provided in the Implementing Rules and Regulations at the expense of the person, firm or corporation found to be in violation thereof.

CHAPTER XV

TRANSITORY PROVISION

SECTION 59. Implementing Rules and Regulations. ? The Secretary shall within ninety (90) days from the effectivity of this Act convene a technical working committee composed of representatives from the National Meat Inspection Service, Bureau of Animal Industry, Bureau of Food and Drugs and one (1) representative each from the League of Cities and the League of? Municipalities to formulate in consultation with the private sector the necessary implementing rules and regulations. The implementing rules and regulations shall be submitted to the Committee on Agriculture of both Houses of Congress for prior approval.

CHAPTER XVI

MISCELLANEOUS AND FINAL PROVISIONS

SECTION 60. Separability Clause. ? if any portion or provision of this Code is declared invalid or unconstitutional, the other portions or provisions not affected thereby shall continue to be in full force and effect.

SECTION 61. Repealing Clause. - All existing laws, decrees, executive orders and rules and regulations or Parts thereof which are inconsistent with this Code, are hereby repealed or modified accordingly.

SECTION 62. Effectivity ? This Code shall take effect thirty (30) days after its complete publication in the Official Gazette or in two (2) newspapers of general circulation, whichever comes first.

Approved,

This act is a consolidation of Senate Bill No. 2691 and House Bill No. 6587 was finally passed by the Senate and the House of Representatives on February 6, 2004 and February 7, 2004, respectively.

Approved: May 12, 2004

President of The Philippines

An Act Modernizing The Professional Regulations Commission,
Repealing For The Purpose Pd 223 Entitled "Creating The Professional
Regulation Commission And Prescribing Its Powers And Functions"
And For Other Purpose

Republic of the Philippines

CONGRESS OF THE PHILIPPINES

Metro Manila

Eleventh Congress

Third Regular Session

Began and held in Metro Manila, on Monday, the twenty-fourth day of July, two thousand

Republic Act 8981

AN ACT MODERNIZING THE PROFESSIONAL REGULATIONS COMMISSION, REPEALING FOR THE PURPOSE PD 223 ENTITLED ?CREATING THE PROFESSIONAL REGULATION COMMISSION AND PRESCRIBING ITS POWERS AND FUNCTIONS? AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1. Title. ? This act shall be called the ?PRC Modernization Act of 2000?.

Section 2. Statement of Policy. ? The State recognizes the important role of professionals in nation-building and, towards this end, promotes the sustained development of a reservoir of professionals whose competence has been determined by honest and credible licensures and whose standards of professional service and practice are internationally recognized and considered world-class brought about by regulatory measures, programs and activities that foster professional growth and advancement.

Section 3. Professional Regulation Commission. ? There is hereby created a three-man commission to be known as the Professional Regulation Commission, herein referred to as the Commission, which shall be attached to the Office of the President for general direction and coordination.

Section 4. Composition. ? The Commission shall be headed by one (1) full-time Chairperson and two (2) full-time Commissioners all to be appointed by the President for a term of seven (7) years without reappointment to start from the time they assume office. Appointments to a vacancy that occurs before the expiration of the term of a Commissioner shall cover only the unexpired term of the immediate predecessor. At the expiration of the term of the Chairperson, the most senior of the Commissioners shall temporarily assume and perform the duties and functions of the Chairperson until a permanent Chairperson is appointed by the President.

The Chairperson or Commissioners shall be at least forty (40) years of age, holding a valid certificate of registration/professional license and a valid professional identification card or a valid certificate of competency issued by the Commission or a valid professional license issued by any government agency, familiar with the principles and methods of professional regulation and/or licensing and has had at least five (5) years of executive or management experience: Provided, That one (1) of the Commissioners must be a past Chairperson/members of a Professional Regulatory Board.

Section 5. Exercise of Powers and Functions of the Commission. ? The Chairperson of the Commission, and the Commissioners as members shall sit and act as a body to exercise general administrative, executive and policy-making functions of the Commission. The Commission shall establish and maintain a high standard of admission to the practice of all professions and at all times ensure and safeguard the integrity of all licensure examinations.

The Chairperson shall act as the presiding officer and chief executive officer of the Commission. As presiding officer, he/she shall preside over the meetings of the Commission sitting as a collegial body. As chief executive officer of the Commission, he/she shall be responsible for the implementation of the policies and programs adopted by the Commission for the general administration of the Commission. He/She shall perform such other activities which are necessary for the effective exercise of the powers, functions and responsibilities of the Commission.

Section 6. Compensation and Other Benefits. ? The Chairperson shall receive compensation and allowances equivalent to that of a Department Secretary while the Commissioners shall receive the compensation and allowances equivalent to that of an Undersecretary. The Chairperson and the members of the Commission shall be entitled to retirement benefits provided under RA 1568, as amended by RA 3595.

Section 7. Powers, Functions and Responsibilities of the Commission. ? The powers, functions and responsibilities of the Commission are as follows:

a. To administer, implement and enforce the regulatory policies of the national government with respect to the regulation and licensing of the various professions and occupations under its jurisdiction including the enhancement and maintenance of professional and occupational standards and ethics and the enforcement of the rules and regulations thereto;

b. To perform any or all acts, enter into contracts, make such rules and regulations and issue such orders and other administrative issuances as may be necessary in the execution and implementation of its functions and the improvement of its services;

c. To review, revise and approve resolutions, embodying policies promulgated by the Professional Regulatory Boards in the exercise of their powers and functions or in implementing the laws regulating their respective professions and other official actions on non-ministerial matters within their respective jurisdictions.

d. To administer and conduct the licensure examinations of the various regulatory boards in accordance with the rules and regulations promulgated by the Commission; determine and fix the places and dates of examinations; use publicly or privately owned buildings and facilities for examination purposes; conduct more than one (1) licensure examination: Provided, That, when there are two (2) or more examinations given in a year, at least one (1) examination shall be held on weekdays (Monday to Friday): Provided, further, That, if only one (1) examination is given in a year, this shall be held only on weekdays: Provided, finally, That, the Commission is also authorized to require the completion of a refresher course where the examinee has failed to pass three (3) times, except otherwise provided by law; approve the results of examinations and the release of the same; adopt measures to preserve the integrity and inviolability of licensure examinations; appoint supervisors and room watchers from among the employees of the government and/or private individuals with baccalaureate degrees, who have been trained by the Commission for the purpose and who shall be entitled to a reasonable daily allowance for every examination day actually attended, to be determined and fixed by the Commission; publish the list of successful examinees; provide schools, colleges and universities, public or private, offering courses for licensure examinations, with copies of sample test questions on examinations recently conducted by the Commission and copies of the syllabi or terms of specifications of subjects for licensure examinations; and impose the penalty of suspension or prohibition from taking licensure examinations to any examinee charged and found guilty of violating the rules and regulations governing the conduct of licensure examination promulgated by the Commission.

e. To admit successful examinees to the practice of the profession or occupation; cause the entry of their names on its registry book and computerized database; issue certificates of registration/professional license, bearing the registrant?s name, picture and registration number, signed by all members of the Board concerned and the Chairperson, with the official seal of the Board and the Commission affixed thereto which certificate shall be the authority to practice; and at the option of the professional concerned, ministerially issue the professional identification card, to be used solely for the purposes of identification, upon payment of the appropriate amount: Provided, That, marine deck and marine engineer officers shall also be issued endorsement certificates exclusively by the Commission pursuant to the 1978 and 1995 Standards of Training, Certification and Watch keeping (STCW) Convention, to the exclusion of any other government agency, Section 1 (2) of Executive Order No. 149, series of 1999 and provisions of other existing laws, executive orders, administrative issuances/regulations to the contrary notwithstanding: Provided further,That, once a certificate of registration/professional license, or certificate of competency, in the case of marine deck and engine officers are issued, this can not be withdrawn, cancelled, revoked or suspended except for just cause as may be provided by law after due notice and hearing.

f. To have custody of all the records of the various Boards, including examination papers, minutes of deliberation, records of administrative cases and investigations and examination results for control and disposition;

g. To determine and fix the amount of fees to be charged and collected for examination, registration, registration without examination, professional identification card, certification, docket, appeal, replacement, accreditation, including surcharges and other fees not specified under the provisions of RA 465 as amended by RA 1611 to charge and collect reasonable fees at the rates higher than the rates provided there under subject to the approval by the Office of the President;

h. To appoint subject to the Civil Service laws, rules and regulations, officials and employees of the Commission necessary for the effective performance of its functions and responsibilities; prescribe their duties and fix their compensation subject to the provisions of RA 6758 and allowances including other fringe benefits; and to assign and/or reassign personnel as the exigency of the service requires subject to the Civil Service laws, rules and regulations; and to organize or reorganize the structure of the Commission; and create or abolish positions or change the designation of existing positions in accordance with a staffing pattern prepared by it and approved by the Office of the President upon the recommendation of the Department of Budget and Management (DBM) to meet the changing conditions or as the need arises: Provided, That, such changes shall not affect the employment status of the incumbents, reduce their ranks and/or salaries nor shall result in their separation from the service;

i. To submit and recommend to the President of the Philippines the names of licensed/registered professionals for appointment as members of the various Professional Regulatory Boards from among those nominated to fill up vacancies pursuant to the provisions of EO No. 496, series of 1991;

j. Upon recommendation of the Professional Regulatory Board concerned, to approve the registration of and authorize the issuance of a certificate of registration/license and professional identification card with or without examination to a foreigner who is registered under the laws of his state or country and whose certificate of registration issued therein has not been suspended or revoked: Provided, That, the requirements for the registration or licensing in said foreign state or country are substantially the same as those required and contemplated by the laws of the Philippines and that the laws of such foreign state or country allow the citizens of the Philippines to practice the profession on the same basis and grant the same privileges as those enjoyed by the subjects or citizens of such foreign state or country: Provided, That, the Commission may, upon recommendation of the Board concerned authorize the issuance of a certificate of registration/license or a special temporary permit to foreign professionals in the country under reciprocity and other international agreements; consultants in foreign-funded, joint venture or foreign-assisted projects of the government, employees of Philippine or foreign private firms or institutions pursuant to law, or health professionals engaged in humanitarian mission for a limited period of time: Provided, finally, That, agencies organizations or individuals whether public or private, who secure the services of a foreign professional authorized by law to practice in the Philippines for reasons aforementioned, shall be responsible for securing a special permit from the Professional Regulations Commission (PRC) and the Department of Labor and Employment (DOLE) pursuant to PRC and DOLE rules;

k. To authorize any officer of the Commission to administer oaths;

l. To supervise foreign nationals who are authorized by existing laws to practice their professions either as holders of a certificate of registration and a professional identification card or a temporary special permit in the Philippines; to ensure that the terms and conditions for their practice or of their employment are strictly complied with; to require the hiring or employing government agency or private entity/institution to secure a temporary special permit from the concerned Board subject to the approval by the Commission and to file a criminal complaint against the head of the government agency or officers of the said private entity/institution, who shall be liable under the penalty provided for in the concerned professional regulatory law or the penalty imposed pursuant to this Act, when the professional was hired and allowed to practice his/her profession without permit; to file upon due process request for deportation with the Bureau of Immigration and Deportation (BID): and to supervise professionals who were former citizens of the Philippines and who had been registered and issued a certificate of registration and a professional identification card prior to their naturalization as foreign citizens, who may, while in the country on a visit, sojourn or permanent residence, practice their profession: Provided, That, prior to the practice of their profession they shall have first been issued a special permit and updated professional identification card by the Board concerned subject to approval by the Commission and upon payment of the permit and annual registration fees;

m. To monitor the performance of schools in licensure examinations and publish results thereof in a newspaper of national circulation;

n. To adopt and institute a comprehensive rating system for universities, colleges, and training institutes based on the passing ratio and overall performance of students in board examinations;

o. To exercise administrative supervision over the various professional regulatory boards and its members;

p. To adopt and promulgate such rules and regulations as may be necessary to effectively implement policies with respect to the regulation and practice of the professions;

q. To implement the program for full computerization of all licensure examinations given by the various professional regulatory boards including the registration of professionals not later than the year 2003 and other operations of the Commission;

r. To investigate and decide administrative matters involving officers and employees under the jurisdiction of the Commission;

s. To investigate motu proprio or upon the filing of a verified complaint, any member of the Professional Regulatory Boards for neglect of duty, incompetence, unprofessional, unethical, immoral or dishonorable conduct, commission of irregularities in the licensure examinations which taint or impugn the integrity and authenticity of the results of the said examinations and, if found guilty, to revoke or suspend their certificates of registration and professional licenses/identification cards and to recommend to the President of the Philippines their suspension or removal from office as the case maybe;

t. To issue summons, subpoena and subpoena duces tecum in connection with the investigation of cases against officials and employees of the Commission and the members of the Professional Regulatory Boards;

u. To hold in contempt an erring party or person only upon application with a court of a competent jurisdiction;

v. To call or request any department, instrumentality, office, bureau, institution or agency of the government including local government units to render such assistance as it may require, or to coordinate or cooperate in order to carry out, enforce or implement the professional regulatory policies of the government or any program or activity it may undertake pursuant to the provisions of this Act;

w. To initiate an investigation, upon complaint under oath by an aggrieved party, of any person, whether a private individual or professional, local or foreign, who practices the regulated profession or occupation without being authorized by law, or without being registered with and licensed by the concerned regulatory boards and issued the corresponding license/professional identification card or temporary or special permit, or who commits any of the prohibited acts in the regulatory laws of the various professions, which acts are criminal in nature, and, if the evidence so warrants, to forward the records of the case to the office of the city or provincial prosecutor for the filing of the corresponding information in court by the lawyers of the legal services of the Commission who may prosecute said case/s upon being deputized by the Secretary of Justice;

x. To prepare an annual report of accomplishments on the programs, projects and activities of the Commission during the year for submission to Congress after the close of its calendar year and make appropriate recommendations on issues and/or problems affecting the Commission, the Professional Regulatory Board, and the various professions under its jurisdictions; and

y. To perform such other functions and duties as maybe necessary to carry out the provisions of this Act, the various professional regulatory laws, decrees, executive orders and other administrative issuances.

Section 8. Regional Offices ? The Commission is hereby authorized to create regional offices as maybe necessary to carry out their functions as mandated under this Act.

Section 9. Powers, Functions and Responsibilities of the Various Regulatory Boards. ? The various professional regulatory boards shall retain the following powers, functions and responsibilities:

a. To regulate the practice of the professions in accordance with the provisions of their respective professional regulatory laws;

b. To monitor the conditions affecting the practice of the profession or occupation under their respective jurisdictions and whenever necessary, adopt such measures as maybe deemed proper for the enhancement of the profession or occupation and/or the maintenance of high professional, ethical and technical standards, and for this purpose the members of the Board duly authorized by the Commission with deputized employees of the Commission, may conduct ocular inspections in industrial, mechanical, electrical or chemical plants or establishments, hospitals, clinics, laboratories, testing facilities, mines and quarries, other engineering facilities, and in the case of schools, in coordination with the Commission on Higher Education (CHED);

c. To hear and investigate cases arising from violations of their respective laws, the rules and regulations promulgated there under and their Codes of Ethics and, for this purpose, may issue summons, subpoena and subpoena duces tecum to alleged violators and/or witnesses to compel their attendance to such investigations or hearings: Provided, That, the decision of the Professional Regulatory Board shall, unless appealed to the Commission, become final and executory after fifteen (15) days from receipt of notice of judgment or decision;

d. To delegate the hearing or investigation of administrative cases filed before them except in cases where the issue or question involved strictly concerns the practice of the profession or occupation, in which case, the hearing shall be presided over by at least one (1) member of the Board concerned, assisted by a Legal or Hearing Officer of the Commission;

e. To conduct, through the Legal Office of the Commission, summary proceedings on minor violations of their respective regulatory laws, violations of the rules and regulations issued by the boards to implement their respective laws, including violations of the general instructions to examinees committed by the examinees, and render summary judgment thereon, which shall, unless appealed to the Commission, become final and executory after fifteen (15) days from receipt of notice of judgment or decision;

f. Subject to final approval of the Commission, to recommend the registration without examination and the issuance of corresponding certificate of registration and professional identification card;

g. After due process, to suspend, revoke or reissue and reinstate certificates of registration or licenses for causes provided by law;

h. To prepare, adopt and issue the syllabi or tables of specifications of the subjects for examinations in consultation with the academe; determine and prepare the questions for the licensure examinations which shall strictly be within the scope of the syllabus or table of specifications of the subject for examination; score and rate the examination papers with the name and signature of the Board member concerned appearing thereon and submit the results in all subjects duly signed by the members of the Board to the Commission within ten (10) days from the last day of examination, unless extended by the Commission for justifiable cause/s; and subject to the approval by the Commission, determine the appropriate passing general average rating in an examination if not provided for in the law regulating the profession, and;

i. To prepare an annual report of accomplishments on programs, projects and activities of the Board during the year for submission to the Commission after the close of each calendar year and make appropriate recommendations on issues and problems affecting the profession to the Commission.

Section 10. Compensation of the Members of the Professional Regulatory Boards. ? The members of the Professional Regulatory Boards shall receive compensation equivalent to, at least, two salary grades lower than the salary grade of the Commissioners: Provided, That, the Chairperson of the Regulatory Board shall receive a monthly compensation of two steps higher than the members of the Board, and: Provided, further, That they shall be entitled to other allowances and benefits provided under existing laws.

Section 11. Persons to Teach Subjects for Licensure Examination on all Professions. ? All subjects for licensure examination shall be taught by persons who are holders of valid certificates of registration and valid professional licenses of the profession and who comply with the other requirements of the CHED.

Section 12. Assistance of Law Enforcement Agency. ? Any law enforcement agency shall, upon call or request of the Commission or of any Professional Regulatory Board, render assistance in enforcing the regulatory law of the profession including the rules and regulations promulgated there under by prosecuting the violators thereof in accordance with law and the rules of court.

Section 13. Appropriations. ? The amount necessary to carry out the initial implementation of this Act shall be charged against the current year?s appropriations of the Professional Regulation Commission. Thereafter, such sums as maybe necessary for the continued implementation of this Act shall be included in the succeeding General Appropriations Act (GAA).

Section 14. Authority to Use Income. ? In addition to the annual appropriations of the Commission provided under the annual General Appropriations Act (GAA), the Commission is hereby authorized to use its income not exceeding the amount of PhP45,000,000.00 a year for a period of five (5) years after the effectivity of this Act to implement the program for full computerization of the operations of the Commission, subject to the usual accounting and auditing requirements.

Section 15. Penalties for Manipulation and Other Corrupt Practices in the Conduct of Professional Examinations. ?

a. Any person who manipulates or rigs licensure examination results, secretly informs or makes known licensure examination questions prior the conduct of the examination or tampers with the grades in professional licensure examinations shall, upon conviction, be punished by imprisonment of not less than six (6) years and one (1) day to not more than twelve (12) years or a fine of not less PhP50,000.00 to not more than PhP100,000.00 or both such imprisonment and fine at the discretion of the court;

b. In case the offender is an officer or employee of the Commission or a member of the regulatory board, he/she shall be removed from office and shall suffer the penalty of perpetual absolute disqualification from public office in addition to the penalties prescribed in the preceding section of this Act;

c. The penalty of imprisonment ranging from four (4) years and one (1) day to six (6) years or a fine ranging from PhP20,000.00 to not more than PhP49,000.00 or both imprisonment and fine at the discretion of the court, shall be imposed upon the accomplices. The penalty of imprisonment ranging from two (2) years and one (1) day to four (4) years or a fine ranging from PhP5,000.00 to not more than PhP19,000.00 or both imprisonment and fine at the discretion of the court, shall be imposed upon the accessories.

Section 16. Penalties for Violations of Section 7 ? Subparagraph (l) by Heads of Government Agencies or Officers of Private Entities/Institutions. ? Any head of a government agency or officer/s of a private firm/institution which violates Section 7 subparagraph (l) of this Act shall be punished by imprisonment of not less than six (6) months and one (1) day to not more than six (6) years, or a fine ranging from PhP50,000.00 to not more than PhP500,000.00 or both at the discretion of the court.

Section 17. Implementing Rules and Regulations. ? Within ninety (90) days after the approval of this Act, the Professional Regulation Commission, together with representatives of the various Professional Regulatory Boards and accredited professional organizations, the Department of Budget and Management (DBM) and the Commission on Higher Education (CHED) shall prepare and promulgate the necessary rules and regulations needed to implement the provisions of this Act.

Section 18. Transitory Provisions. ? The incumbent Commissioner and two (2) incumbent Associate Commissioners respectively under the terms for which they have been appointed without need of new appointments. The incumbent Executive Director shall likewise serve as Assistant Commissioner without need of new appointment.

Section 19. Separability Clause. ? If any provisions of this Act or the application of such provision to any person or circumstances is declared invalid or unconstitutional, the remainder of this Act or application of such provisions to other persons or circumstance shall not be affected by such declaration.

Section 20. Repealing Clause. ? Republic Act No. 546, Presidential Decree 223, as amended by Presidential Decree No. 657, Republic Act No. 5181 and Executive Order No. 266, Series of 1995 are hereby repealed. Section 23 (h) of Republic Act No. 7836, Section 4 (m & s), Section 23 of Republic Act No. 7920, and Section 29 of Republic Act No. 8050, insofar as it requires completion of the requirements of the Continuing Professional Education (CPE) as a condition for the renewal of the license are hereby repealed. All other laws, orders, rules and regulations or resolutions and all part/s thereof inconsistent with the provisions of this Act are hereby repealed or amended accordingly.

Section 21. Effectivity. ? This Act shall take effect after fifteen (15) days following its publication in the Official Gazette or in two (2) newspapers of general circulation, whichever is earlier.

Approved.

(Sgd.) FRANKLIN M. DRILON (Sgd.) MANUEL B. VILLAR, JR

President of the Senate Speaker, House of Representatives

This Act which is a consolidation of House Bill No. 7572 and Senate Bill 1271 was passed by the House of Representatives and the Senate on October 25, 2000 and October 18, 2000, respectively.

(Sgd.) OSCAR G. YABES (Sgd.) ROBERT P. NAZARENO

Secretary of the Senate Secretary General

House of Representatives

Approved: December 5, 2000

(Sgd.) JOSEPH E. ESTRADA

President of the Philippines